KEI-NIH FOIA Lawsuit for Mark Rohrbaugh Correspondence regarding KEI - April 2021 Production

From: Hammersla, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA]

Sent: 4/16/2018 12:11:27 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Bruff, Susan (NIH/OD) [E]
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=d3bdf8cac94049dcab28d2eb5fad5137-bruffs]

Subject: RE: Exec Sec FYI: KE! and patent reporting

Mark and Susan:
Is this ExSec request for the University of Pennsylvania and Juxtapid? Or is this for another KEI request?

Ann

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Friday, April 13, 2018 10:38 AM

To: Bruff, Susan (NIH/OD) [E] <bruffs@od.nih.gov>; Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>
Subject: Exec Sec FYI: KE] and patent reporting

| know you have seen this correspondence but just wanted to share what | received from the ExSec record and
assignment.

Work Folder Information

Work Folder: WF 371552

Process: FY]

Program Analyst: Crone, Colleen (NIH/OD) [E]

Due Date:

WF Subject: OS forwards for direct reply letter from James Love from Knowledge Ecology International (KEI) requesting
investigation of and remedy to non-disclosure of NIH funding for 5 patents.

IC: od_osp

From: Love, James

To: Azar, Alex

Remarks: Assigned to OTT to create a draft direct reply to James Love on behalf of the Secretary for OD clearance. Please
forward draft to Exec. Sec. to obtain clearances before mailing out. DUE: 04/17/18 COB. Also forwarded as FYI to NINDS,
OIR, OM, OMA, OGC, OCPL, OLPA, and OSP.

REL0000023656

From: Hammersla, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA]

Sent: 4/10/2018 10:43:43 AM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkson, Laura (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=adb561ab47e54fdc94e2a54682514434-berksonld]

cc: Bulls, Michelle G. (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b366f1a4382d44c1bde626e7730c3dd4-bullsmg]; Jackson, Stephanie
(NIH/OD) [C] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=813a0dc9ddbc4fa2be8ca6ea23d081ca-jacksonsg]; Jorgenson, Lyric (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3bbde7d361374981a4d336b6eeb17521-jorgensonla]; Mullman, Lauren
(NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=084e30198ca04156b3c91537del4adb3-mullmanl]

Subject: RE: Exondys 51 patents

Also — this request was sent to the Secretary. While OPERA is looking into the request, we have not heard whether the
Secretary has delegated a response to NIH. The requestors, in addition to asking HHS to take title, has requested a
meeting with the Secretary.

Ann

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, April 09, 2018 6:17 PM

To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>; Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov>
Ce: Bulls, Michelle G. (NIH/OD) [E] <michelle.bulls@nih.gov>; Jackson, Stephanie (NIH/OD) [C]
<stephanie.jackson3@nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E]
<lauren.mullman@nih.gov>

Subject: RE: Exondys 51 patents

Thank you. | was talking to Laura. b5 | These

eee ee ee ee ee eee ee ee eee nett 4

comments are useful background if he chooses to go into more detail.

From: Hammersla, Ann (NIH/OD) [E]

Sent: Monday, April 09, 2018 4:08 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov>
Cc: Bulls, Michelle G. (NIH/OD) [E] <michelle.bulls@nih.gov>; Jackson, Stephanie (NIH/OD) [C]
<stephanie.jackson3@nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E]

<lauren.mullman@nih.gov>
Subject: FW: Exondys 51 patents

All: Thank you Mark for your offer to help. The following is OPERA’s information for the steps of review and options
available.

RELO000023657

From: Hammersla, Ann (NIH/OD) [E]

Sent: Monday, April 09, 2018 11:04 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov>
Cc: Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E] <lauren.mullman@nih.gov>
Subject: RE: Exondys 51 patents

Mark: A little more information may be helpful. | have drafted and it is being reviewed. When ok’d | will send to you
for your review.

Ann

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Friday, April 06, 2018 3:51 PM

To: Berkson, Laura (NIH/OD) [E] <laura.berkson@nih.gov>; Hammersla, Ann (NIH/OD) [E] <hammersiaa@mail.nih.gov>
Cc: Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E] <lauren.mullman@nih.gov>
Subject: RE: Exondys 51 patents

oy
O1

Ann: can we work on this together? Not sure if you to say more about OER’s steps and processes.

From: Berkson, Laura (NIH/OD) [E]
Sent: Friday, April 06, 2018 3:07 PM
To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Cc: Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>; Mullman, Lauren (NIH/OD) [E] <lauren.mullman@nih.gov>
Subject: RE: Exondys 51 patents

Hi Mark,

RELO000023657

Thanks for flagging this. Dr. Collins is testifying in front of the House Appropriations L-HHS Subcommittee on
Wednesday, April 11 and we want to make sure he is prepared in case this comes up. Can you help pull together some
talking points? We would need something by Monday afternoon. im hoping we can pull from previous march-in
bullets. NINDS pulled together some background bullets (see below}, but | think we need something that would be
responsive to a question. I've taken a first stab at drafting a mock question and left a spot for aresponse. Feel free to
make edits to that or the NINDS background.

Happy to chat if that would be helpful.

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Wednesday, April 04, 2018 5:19 PM

To: Wolinetz, Carrie (NIH/OD) [E] <carrie.wolinetz@nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>;
Baker, Rebecca (NIH/OD) [E] <rebecca.baker@nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Berkson,

Laura (NIH/OD) [E] <laura.berkson@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: FW: Exondys 51 patents

KEI, Health GAP, Patients for Affordable Drugs, People of Faith for Access to Medicines, Social Security Works, and
Universities Allied for Essential Inventions sent Ann Hammersla a copy of a letter they plan to send to Secy Azar

RELO000023657

tomorrow (cc’ing Daniel Levinson HHS OIG) asserting that inventors/institutions failed to disclose NIH funding on 5
relevant patents on Serapta’s Exondys 51 (eteplirsen), a treatment for DMD, “which provides the government with an
opportunity to take title to patents, and to use the ownership of the patents as leverage to lower the price.” KEI also
suggests that “the NIH and the U.S. Department of Defense review 91 other patents

assigned to Sarepta which do not disclose federal research funding.” He asks for a meeting with the HHS.

From: Hammersla, Ann (NIH/OD) [E]

Sent: Wednesday, April 04, 2018 3:40 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>
Subject: FW: Exondys 51 patents

FYI

From: James Love <james.love@keionline.org>

Sent: Wednesday, April 04, 2018 1:08 PM

To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>

Ce: Andrew S. Goldman <andrew.goldman@keionline.org>; Kim Treanor <kim.treanor@keionline.org>
Subject: Exondys 51 patents

Dear Ann Hammersla,

| am attaching two PDF files that we are sending tomorrow, regarding the patents on Exondys 51, so you have
a heads up.

Jamie

James Love. Knowledge Ecology International
http://www.keionline.org/donate. html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile: +41.76.413.6584, twitter.com/jamie_ love

RELO000023657

From: Joe Allen [jallen@allen-assoc.com]

Sent: 4/5/2017 2:10:34 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=O0D/cn=ROHRBAUM]; Hammersla, Ann (NIH/OD) [E]
[/O=NIH/OU=NIHEXCHANGE/cn=Recipients/cn=hammerslaa]

Subject: Rep. Doggett's press release on letter to Pres Trump on using march in rights to control drug prices

FYI:

(https://doggett.house.gov/media-center/press-releases/congressional-democrats-trump-we-re-calling-your-
hand-lower-prescription)

Congressional Democrats to Trump: “We’re Calling
Your Hand -- Lower Prescription Drug Prices”

April 4, 2017

Washington, D.C.—Today, 51 members of Congress, led by U.S. Congressman Lloyd Doggett (D-TX), urged
President Donald Trump to fulfill his oft-repeated promise to lower prescription drug prices. Rep. Doggett and
his colleagues asked President Trump to protect public access to drugs developed with public dollars. Rep.
Doggett, a senior member of the Ways and Means Committee and a leader of the House Prescription Drug Task
Force, said:

“Today, we are calling Trump’s hand on his promises to lower prescription drug prices. To date
he has failed completely to fulfill his commitment. So far his only related legislative action was
to endorse a $28.5 billion tax windfall for brand name drug makers, while seeking nothing in
return for consumers. He can act immediately to discourage many drug makers from charging
the public sky-high prices on drugs developed with public dollars.

“When taxpayers finance pharmaceutical research, they have earned the right to obtain
affordable access to that medication. And that is not happening now. Instead, taxpayers are hit
twice for too many drugs—once when they pay for drug research and again when the
pharmaceutical company engages in price gouging. When drug makers are granted unrestricted,
government-approved monopolies and exploit them to set monopoly prices, a diagnosis of a
dread disease can become a prognosis for financial ruin.”

The letter explains that federal agencies, like the National Institutes of Health (NIH), can foster competition by
requiring companies holding patents for publicly-funded inventions to license the patent to third parties. This
authority was created by the Bayh-Dole Act, a 1980 statute, and can be used when “action is necessary to
alleviate health and safety needs which are not being reasonably satisfied” or when the benefits of the taxpayer-
funded drug are not “available to the public on reasonable terms.” This effort is supported by Public Citizen,
Doctors for America, Consumers Union, and Knowledge Ecology International. The Prescription Drug Task
Force aims to advance legislative and administrative solutions to lower the cost of prescription medications for
American families.

REL0000023662

Joseph P. Allen
President

Allen and Associates
60704 Rt. 26, South
Bethesda, OH 43719

(ey b6

www.allen-assoc.com

REL0000023662

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]

Sent: 8/27/2019 1:59:17 PM

To: Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]; Rohrbaugh, Mark (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Goldstein, Bruce (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cb67e8fe5aa2452a8a7f200e5fb4335b-goldsteb]; Pazman, Cecilia
(NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]

Subject: Re: Emailing: KEl Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoKE! re MTTI 25Aug2019.docx

Ok, Ill simplify.

From: "Berkley, Dale (NIH/OD) [E]" <berkleyd@od.nih.gov>

Date: Monday, August 26, 2019 at 16:23:16

To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Rohrbaugh, Mark (NIH/OD)
[E]" <rohrbaum@od.nih.gov>

Ce: "Goldstein, Bruce (NIH/OD) [E]" <goldsteb@mail.nih.gov>, "Pazman, Cecilia (NIH/NHLBI) [E]"
<pazmance(@nhibi.nih.gov>

Subject: RE: Emailing: KE] Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoKEI re
MTTI 25Aug2019.docx

----- Original Message-----

From: Shmilovich, Michael (NIH/NHLBJ) [E] <michael.shmilovich@nih.gov>

Sent: Monday, August 26, 2019 4:03 PM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>
Ce: Goldstein, Bruce (NIH/OD) [E] <goldsteb@mail.nih.gov>; Pazman, Cecilia (NIH/NHLBD [E]
<pazmance@pnhlbi.nih.gov>

Subject: RE: Emailing: KE] Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoK EI re MTTI
25Aug2019.docx

Importance: High

Their listed of comments were essentially the same as before.

From: Berkley, Dale (NIH/OD) [E]

Sent: Monday, August 26, 2019 15:57

To: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<rohrbaum@od.nih.gov>

Ce: Goldstein, Bruce (NIH/OD) [E] <goldsteb@mail-nih.gov>; Pazman, Cecilia (NIH/NHLBD [E]
<pazmance@nhlbi.nih.gov>

Subject: RE: Emailing: KEI Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoK EI re MTTI
25Aug2019.docx

REL0000023665

Misha:

I don't see any objections or even any questions from KEI in their August 23 letter that you attached. Have I missed any?

[fon ee eee eee ee RR em

Best, Dale

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch Bldg. 31, Rm. 47 Bethesda, MD 20892

301-496-6043

301-402-2528(Fax)

This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is
PROTECTED or PRIVILEGED, and it should not be disseminated, distributed, or copied to persons not authorized to
receive such information.

From: Shmilovich, Michael (NIH/NHLBJ [E] <michael.shmilovich@nih.gov>

Sent: Sunday, August 25, 2019 7:47 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>; Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>
Ce: Goldstein, Bruce (NIH/OD) [E] <goldsteb@mail.nih.gov>; Pazman, Cecilia (NIH/NHLBD [E]
<pazmance@nhlbi-nih.gov>

Subject: Emailing: KEI Comments NIH License to MTTI Described in 84 FR 39001 _.pdf, NIHtoKEI re MTTI
25Aug2019.docx

Dale and Mark -- a pdf with KEI's comments (received Aug 23) and a word doc with my response enclosed. Please have
a look at both and let me know if you have any comments or edits to the response.

Thanks again!

Regards,

Michael A. Shmilovich, Esq., CLP

Office of Technology Transfer and Development
31 Center Drive Room 4A29, MSC2479
Bethesda, MD 20892-2479

0. 301.435.5019

shmilovm@mail.nih.gov

This message may contain privileged and confidential information intended only for the use of the individual(s) or entity
named above. If you are not the intended recipient, you are hereby notified that any use, dissemination, distribution, or
copying of this message or its content is strictly prohibited. If you have received this message in error, please notify
sender immediately and destroy the message without making a copy. Thank you.

“Always be yourself....unless you can be a pyrate... then; obviously, be a pyrate”

‘Your message is ready to be sent with the following file or link attachments:

KEI Comments NIH License to MTTI Described in 84 FR 39001_.pdf NIHtoKEI re MTTI 25Aug2019.docx

REL0000023665

Note: To protect against computer viruses, e-mail programs may prevent sending or receiving certain types of file
attachments. Check your e-mail security settings to determine how attachments are handled.

REL0000023665

From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]

Sent: 8/27/2019 2:29:01 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: RE: Questions Regarding NIH's Prospective Grant of an Exclusive Patent License: Development and

Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell
Malignancies

Ok thanks.

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528(Fax)

This message is intended for the exclusive use of the recipient(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated,
distributed, or copied to persons not authorized to receive such information.

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Sent: Tuesday, August 27, 2019 10:28 AM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>

Subject: Re: Questions Regarding NIH's Prospective Grant of an Exclusive Patent License: Development and
Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies

| saw your response to Misha and will work with jim in a similar vein

Sent from my iPhone

On Aug 27, 2019, at 10:22 AM, Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov> wrote:

Parente tere imei momen nrment er mI mee eile EINE IESE IEEE Riese eee SIE Ie RIE EaCE IEEE Era aa eteSiatmatamiassmtaaiarmiaimemimimies a

More and more questions. | b5

Sent from my iPhone

Begin forwarded message:

From: "Knabb, Jim (NIH/NCI) [E]" <jim.knabb@nih.gov>

Date: August 27, 2019 at 8:57:25 AM EDT

To: "Rohrbaugh, Mark (NIH/OD) [E]" <rohrbaum @od.nih.gov>

Subject: FW: Questions Regarding NIH's Prospective Grant of an Exclusive Patent
License: Development and Commercialization of CD19/CD22 Chimeric Antigen
Receptor (CAR) Therapies for the Treatment of B-Cell Malignancies

Hi Mark,

| hope you are doing well. | see that you’re out of the office, | hope you’re enjoying a
vacation.

Could we work together to craft a response to KEI regarding their comments below? My

understanding from Richard isi_ b5

i
i
inert rrr terete seem emimemre reeeee teers tense AMAT RAY MET RAT RRR APT LETT APTA ATTY RPT PR YP
i
i
i
i
i

i b5

REL0000023667

Thanks,
Jim

From: kathryn ardizzone <kathryn.ardizzone@keionline.org>

Sent: Friday, August 23, 2019 4:57 PM

To: Knabb, Jim (NIH/NCI) [E] <jim.knabb@nih.gov>

Cc: James Love <james.love@keionline.org>

Subject: Questions Regarding NIH's Prospective Grant of an Exclusive Patent License:
Development and Commercialization of CD19/CD22 Chimeric Antigen Receptor (CAR)
Therapies for the Treatment of B-Cell Malignancies

Dear Dr. Knabb:

We are writing to request information about the proposed exclusive
license in CAR therapies targeting certain B-cell cancers, which was
noticed at 84 FR 43148, to Lyell Immunopharma, Inc. (“Lyell”), located in
South San Francisco, CA.

1. According to the notice, there are two inventions covered by the proposed
license, described at OTT Ref. Nos. E-016-2015 and E-017-2017.

a. What clinical trials are associated with the subject inventions? We
are aware of only one trial, NCT01593696, which is associated
with E-016-2015.

b. Can you please confirm that this trial is associated with the
licensed technology?

c. How much will the NIH contribute to the cost of NCT01593696? A
research on the NIH RePORTER database for NCT01593696 for
all fiscal years returned zero results.

d. Are there any other clinical trials are associated with these
technologies? If so, what NIH grant numbers, if any, associated
with each trial, and how much did each trial cost?

2; Please confirm the stages of research and development that has
been completed or started for each invention.

>. What is the NIH’s rationale for concluding that an exclusive, rather
than a non-exclusive, or a partially-exclusive license is a necessary
incentive under 35 U.S.C. § 209?

a. Did the NIH estimate the amount of investment required to bring the
technology to practical application?

b. Did the NIH consider the incentives from the Orphan Drug Act
regulatory exclusivity for rare diseases or FDA rules on exclusive rights to
rely on regulatory test data as inadequate to protect the private investment
in the technology?

4. What is the period of exclusivity for the proposed exclusive license?
a. NIH’s model exclusive license, located at
https://www.ott.nih.gov/resources#MLA, does include duration as a
standard term. As a general matter, does the NIH negotiate the period of
exclusivity for proposed licenses?

b. If the NIH does not negotiate duration as a term of its licenses, why
not? How is this consistent with 35 U.S.C. § 209?

REL0000023667

c. CAR technologies are promising new cancer treatments, yet costs
hundreds of thousands of dollars, straining hospital budgets and
threatening patient access. From the industry perspective, they can be
highly lucrative technologies. Has the NIH undertaken an economic
analysis to determine if a shorter exclusivity period such as a five or 10
year term would be a sufficient incentive under 35 U.S.C. § 209 for the
licensed technologies?

=A The proposed territorial application of the license is “worldwide.”
NIH’s licensing page, https://www.ott.nih.gov/licensing, states that
“[w]here appropriate, licenses can be granted on a worldwide
basis.”"(Emphasis added). Determining the territorial application of a

license on a case-by-case basis would comport with 35 U.S.C. § 209. Yet,
KEI rarely encounters a licensing notice where the proposed field of use is

not worldwide.

a. Did the NIH consider any of the benefits of licensing the technology

on an exclusive basis in some but not all countries?

6. What are the proposed royalties and other terms of financial
compensation for this proposed exclusive license?

a. What licensing guidelines, if any, does the NIH Office of
Technology Transfer use to determine royalty rates for its licenses?

b. What are the average royalty rates for licenses in NIH-owned CAR

therapies, as well as the average royalty rates for NIH license for cancer
therapeutics.

re How has the NIH, through the proposed license, sought to give
effect to the policy objective in the “United States Public Health Service
Technology Transfer Policy Manual, Chapter No. 300, PHS Licensing
Policy,” which states the following: “PHS seeks to promote commercial
development of inventions in a way that provides broad accessibility for
developing countries”? How has the NIH contemplated how its licensing
decisions affect access to CAR therapies in developing countries?

a. If the license is worldwide, how will the NIH ensure access in
countries with lower incomes, given the lack of access to other CAR T
treatments in developing countries?

8. Has the NIH sought the advice of the Attorney General under 40
U.S.C. § 559?

Thank you in advance for your consideration of these questions.
Sincerely,

Kathryn Ardizzone, Esq.

Counsel

Knowledge Ecology International

1621 Connecticut Avenue NW, Suite 500
Washington, DC 20009

kathryn.ardizzone@keionline.org
(202) 332-2670

REL0000023667

From: Buchbinder, Barry (NIH/NIAID) [E] [/O=NIH/OU=NIHEXCHANGE/CN=NIAID/CN=BBUCHBINDER]

Sent: 3/16/2017 2:28:50 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=O0D/cn=ROHRBAUM]
Subject: FW: ACTION - Fwd: Anyone have objection from KEl in 2017

Mark,

As an excuse to write you .... :-)

KEI lists their activities on their home page (<http:/Awww.keionline.org/>, scroll down). A quick look (“quick” => | might
have missed something) found nothing in 2017 stood out as relevant. Note that Zika is listed <http://keionline.org/zika>,
so it seems to be pretty up to date.

Hope you're having fun!

- Barry
Ee: ‘NIAID/NIH = 240-627-3678 / Fax: 240-827-3717 }

tps ned .nih.gov/search/View Details aspx?NiHiD=00 10146018

‘aD16 « o8.2844 |

« The information in this e-mail and any of its attachments is confidential and may contain sensitive information. « it should not be used by anyone who is not an intended recipient. > If you have received this e-mail in error, please inform the
sender and delete it from your mailbox or any other storage devices. = NIAID shall not accept liability for any statements made that are sender's own and nol expressly made on behalf of the NIAID by one cf its representatives.

From: Buchbinder, Barry (NIH/NIAID) [E]

Sent: Thursday, March 16, 2017 10:00 AM

To: Salata, Carol (NIH/NIAID) [E] <CSalata@niaid.nih.gov>; Castiblanco, Diana (NIH/NIAID) [C]
<diana.castiblanco@nih.gov>; Contreras, Vince (NIH/NIAID) [E] <vince.contreras@nih.gov>; Petrik, Amy (NIH/NIAID) [E]
<petrika@niaid.nih.gov>

Subject: RE: ACTION - Fwd: Anyone have objection from KEI in 2017

Carol, I'm not aware of any objections.
All:

To save you looking for who this is (like | had to), KEI = Knowledge Ecology International (<http://Awww.keionline.org/>;
<https://en.wikipedia.org/wiki/Knowledge Ecology International>), Jamie Love's group.

In case you want to look at it, the objection and related items seem to be here <http://keionline.org/zika>.
Also, KEI lists their activities on their home page (scroll down) — nothing in 2017 stood out as relevant.
Best,

- Barry
TTIPO:NIAID: NIH 8 | 240- 627-3678 { Fax: 240-627-3117 /

& ar information in e-mail and any “ofits ean ents is confidential and may contain sensitive information. - It should not be used by anyone who is not an intended recipient. « if you have received this e-mail in error, please inform the
sender and delete it from your mailbox or any other storage devices. » NIAID shail not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its represeniatives.

From: Salata, Carol (NIH/NIAID) [E]

Sent: Thursday, March 16, 2017 6:57 AM

To: Buchbinder, Barry (NIH/NIAID) [E] <BBuchbinder@niaid.nih.gov>; Castiblanco, Diana (NIH/NIAID) [C]
<diana.castiblanco@nih.gov>; Contreras, Vince (NIH/NIAID) [E] <vince.contreras@nih.gov>; Petrik, Amy (NIH/NIAID) [E]

<petrika@niaid.nih.gov>
Subject: FW: ACTION - Fwd: Anyone have objection from KEI in 2017

Please let me know of any objections you are aware of.
Thanks,
Carol

RELO000023668

From: Feliccia, Vincent (NIH/NIAID) [E]

Sent: Wednesday, March 15, 2017 6:44 PM

To: Salata, Carol (NIH/NIAID) [E] <CSalata@niaid.nih.gov>; Green, Wade (NIH/NIAID) [E] <wade.green@nih.gov>
Subject: FW: ACTION - Fwd: Anyone have objection from KEI in 2017

RE: Any Objections from KE! in 2017?

Hi Carol and Wade,

Please confirm with your Teams that we have not received any objections fram KElin 2047.
Thanks,

Vince

aie 8 fs Se os oie Os oie a oe

Vincent L. Feliccia, Ph.D., J.D.

Branch Chief

Vaccine Design, Allergic and Infectious Diseases Branch (VDAID)

Technology Transfer and Intellectual Property Office (TTIPO}

National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH}
5601 Fishers Lane, Suite 6D

MSC 9804

Bethesda, Maryland 20892-9804 [Courler: Rockville, Maryland 20852-9804]

Office: (240) 627-3687
Mobile: (240) 620-2647
Fax: (240) 627-3117

vieliccla@niaid.nih.gav

The information in this e-mail and any of its attachments is confidential and may contain sensitive information. it should
not be used by anyone who is not the original intended recipient. [f you have received this e-mail in error please inform
the sender and delete it from your mailbox or any other storage devices. National Institute of Allergy and Infectious
Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of
the NIAID by one of its representatives.

From: Mowatt, Michael (NIH/NIAID) [E]

Sent: Monday, March 13, 2017 8:05 PM

To: Feliccia, Vincent (NIH/NIAID) [E] <VFeliccia@niaid.nih.gov>; Sayyid, Fatima (NIH/NIAID) [E] <fatima.sayyid@nih.gov>;
Williams, Richard (NIH/NIAID) [E] <RWILLIAMS @niaid.nih.gov>

Ce: Frisbie, Suzanne (NIH/NIAID) [E] <frisbies@otd.nci.nih.gov>; Ranjan, Mukul (NIH/NIAID) [E]

<MRanjan@niaid.nih.gov>
Subject: ACTION - Fwd: Anyone have objection from KE! in 2017

Branch chiefs,

Please let me know what we've got on this.

RELO000023668

To my knowledge none.
Thx,

Mike

Begin forwarded message:

From: "Rohrbaugh, Mark (NIH/OD) [E]" <RohrBauM@OD.NIH.GOV>
Date: March 13, 2017 at 5:00:29 PM EDT

To: NIH TDC Long <niaaatdcl-l@mail.nih.gov>

Subject: Anyone have objection from KEI in 2017

From FR notice of intent to grant?

Thx
Mark

Sent from my iPhone

RELO000023668

From: Joe Allen [jallen@allen-assoc.com]

Sent: 3/16/2017 7:19:53 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]

Subject: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in lonis Pharmaceuticals’
Spinraza

FYI

Sent from my iPhone

See link below for press release that KEI posted this morning. The Inspector General’s
Office has declined to investigate the federal funding issue for Spinraza.

http://keionline.org/node/2744

REL0000023670

From: Robert Hardy [RHardy@COGR.edu]

Sent: 3/17/2017 7:24:44 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]
Subject: FW: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in lonis

Pharmaceuticals’ Spinraza
Attachments: 18Jan2017-OlG-investigation-Request-Nusinersen-Patents. pdf

Mark,

Good to see you at AUTM. Hope you got back OK.

Here FY! is the response by the HHS OIG to the KE! request, as well as the original letter from KEI.

From: Susalka, Stephen [mailto:SSusalka@autm.net]

Sent: Friday, March 17, 2017 11:55 AM

To: Robert Hardy; Joe Allen; Willey, Teri

Cc: Fred Reinhart; Michael Waring; Ashley Stevens (astevens@fipglic.com)

Subject: RE: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis
Pharmaceuticals’ Spinraza

Dear Bob,

| attached the official letter they sent to HHS to this email and their website has the following information:

HAS Of ice of Inspector General Declines to Investiqate Fallure to
MAO WTC OF TS OOCTOP Generar WOCHMNeS LO MIVeESUCaLe Fanure
ry «a rtaral Cane ‘ 7 ig’

The Depariment of Health and Human Services Office of Inspector General (O1G) informed KEI that it would not move
forward with an investigation into whether Isis Pharmaceuticals, now known as lonis Pharmaceuticals, failed to report
federal funding in patents on Spinraza.

in a letter dated March 13, 2017, Matthew Charette, the Special Agent in Charge of the Investigations Branch of O1G,
explained that OIG counsel believes that OlG has limited authority, and that the obligation fo “monitor]] Invention reporting
and remedyi] noncompliance” “rests with NIH's Office of ees for Extramural Research Administration (OPERA)."

On January 18, 2077, SE a 2e-padge i {3 containing evidence that the patents on Spinraza benefited
frorn federal grants. KEI did not just ask OIG to iP veetguta Isis' alleged failure to report this funding, in violation of the
Bayh-Dole Act and federal requiations, but also urged the OIG “to investigate whether the National institutes of Health
failed to conduct proper oversight in administering its grants” and to "recommend appropriate action to remedy the
situation in line with the statute and prior decisions with regard to failure to disclose a subject invention.”

Spinraza is used to treat Spinal Muscular Atrophy (SMA), a debilitating illness that largely affects very young children.
Biogen, which collaborates with lonis, sells Spinraza for a price of $750,00 for the first year of four injections, and
$375,000 for every year thereafter. As explained in KE!'s original letter fo OIG, lonis worked with researchers at Cold
Spring Harbor Laboratories who received federal funding for their work on a treatment for SMA. We also noted that failure

REL0000023672

to disclose federal funding affects the ability of the government to use march-in rights or its royalty-free rights in patents
under the Bayh-Dole Act.

and transcribed below.

The letter from is avaiable @s @ or

Sincerely,
Steve

Stephen J. Susalka, Ph.D., CLP

Chief Executive Officer

Association of University Technology Managers (AUTM)
Advancing Discoveries for a Better World

(336) 546-7977

Ssusalka@autm.net

From: Robert Hardy [mailto:RHardy@COGR.edu]
Sent: Friday, March 17, 2017 11:51 AM

To: Joe Allen <jallen@allen-assoc.com>; Willey, Teri <twilley@cshl.edu>
Cc: Fred Reinhart <fred@research.umass.edu>; Michael Waring <mwaring@umich.edu>; Susalka, Stephen
<SSusalka@autm.net>; Ashley Stevens (astevens@fipgiic.com) <astevens@fipgilc.com>

REL0000023672

Subject: RE: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in lonis
Pharmaceuticals’ Spinraza

Can someone please send me the text of the KEI press release?

Thanks. KEL denies me access ta their website.

From: Joe Allen [mailto:jallen@allen-assoc.com]

Sent: Thursday, March 16, 2017 3:26 PM

To: Willey, Teri

Cc: Fred Reinhart; Michael Waring; Susalka, Stephen; Ashley Stevens (astevens@fipgllc.com); Robert Hardy
Subject: Re: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding in Ionis
Pharmaceuticals’ Spinraza

This keeps Jamie's perfect streak (for having every petition denied) intact. He's the Cal Ripken for that category
Sent from my iPhone
On Mar 16, 2017, at 3:15 PM, Willey, Teri <twilley@cshl.edu> wrote:

And we are continuing to diligently bring all our reporting into compliance. No rest for the wicked.

From: Frederick Reinhart [mailto:fred@research.umass.edu]

Sent: Thursday, March 16, 2017 3:14 PM
To: Joe Allen

Subject: Re: HHS Office of Inspector General Declines to Investigate Failure to Disclose Federal Funding
in Ionis Pharmaceuticals’ Spinraza

Ditto. No doubt they will continue to press the issue.
Sent from my iPhone
On Mar 16, 2017, at 2:54 PM, Joe Allen <jallen@allen-assoc.com> wrote:
Best news of the day!
Sent from my iPhone
On Mar 16, 2017, at 2:02 PM, Willey, Teri <twilley@cshl.edu> wrote:
Sharing some positive news
See link below for press release that KEI posted this morning. The
Inspector General’s Office has declined to investigate the federal

funding issue for Spinraza.

http://keionline.org/node/2744

REL0000023672

RNOWLEDGE ECOLOGY
INTERNATIONAL

1622 Connecticut Ave NW Suite 500
Washington, D.C. 20009
+1 (202) 332-2670

January 18, 2017

The Honorable Daniel R. Levinson

U.S. Department of Health & Human Services
Office of Inspector General

330 Independence Avenue, SW

Washington, DC 20201

via email: Dan.Levinson@oig.hhs.gov

Dear Inspector General Levinson:

RE: Allegation of Isis Pharmaceuticals Failure to Satisfy Disclosure Requirements
for a Subject Invention Under the Bayh-Dole Act, 35 U.S.C. §§ 200 et seq.

This letter requests that you investigate substantial evidence that Isis Pharmaceuticals (now
known as lonis Pharmaceuticals) and Cold Spring Harbor Laboratory failed to satisfy
disclosure requirements under the Bayh-Dole Act, 35 U.S.C. §§ 200 et seg., and Federal
regulations, 37 C.F.R. §§ 401.3(a) & 401.14, with regard to federally-funded subject inventions
related to the composition and methods of use of nusinersen, an antisense oligonucleotide
(ASO), for the treatment of spinal muscular atrophy (SMA), embodied in U.S. Patent Nos.
8,361,977 (hereinafter the “977 patent”) and 8,980,853 (hereinafter the “853 patent’).

We have a high degree of confidence that both the ’977 patent and the ’853 patent are
subject inventions under the Bayh-Dole Act, in that they were “conceived or first actually
reduced to practice in the performance of work under a funding agreement.” 35 U.S.C. §
201(e).

Specifically, we present evidence that both inventions benefitted from the grant of funds from
the National Institutes of Health (NIH) to support the research of Dr. Adrian R. Krainer at Cold
Spring Harbor Laboratory, which was then used to file patents that have been assigned to Isis.

KEI Nusinersen Patent Complaint, Page 1 of 22

REL0000023672.0001

In addition, the National Institutes of Health (NIH) gave several grants to Isis, and those
grants appear to have directly contributed to the reduction to practice of the patented
inventions assigned to Isis.

Table of Contents

I. About Us 2

lil. Spinal Muscular Atrophy (SMA) and Nusinersen (Spinraza) 3

i.A. Spinal Muscular Atrophy Incidence, Presentation, and Genetics 3

Table II.1: Classifications of Spinal Muscular Atrophy (SMA) 3

ll.B. Nusinersen (Spinraza) Mechanism of Action and Efficacy 4

lil. The Bayh-Dole Act and Disclosure of Subject Inventions 5
IV. The Nusinersen Patent Landscape and Failure to Disclose Government Rights in a

Subject Invention 9

Table IV.1: Key United States Patents in Nusinersen 9

IV.A. The University of Massachusetts Patents 10

IV.B. The ’977 and ’853 Patents: Failure to Disclose Government Rights in the Patents 11

Figure IV.1: Timeline of Publications, Collaborations, and Patent Filings/Grants 14

IV.B.1 Federal grants to ISIS Pharmaceuticals 16

V. Remedies 17

VI. Concluding Comments 17

Appendix |: Information on Misc Grants 19

1. Adrian R. Krainer/Cold Spring Harbor Laboratory Grant No. GM42699 19

2. Isis Pharmaceuticals’ Grants from REPORTER query 20

3. Selected DoD Army and DARPA SBIR and STTR grants 22

I. About Us

Knowledge Ecology International (KEI) is a 501(c)(3) non-profit non-governmental
organization based in Washington, D.C., that advocates for access to affordable medicines,
with a focus on human rights and social justice.

KEI has conducted oversight of federal intellectual property policy as it relates to
federally-funded inventions. Over the years, we have filed petitions and comments with

various federal agencies, including the National Institutes of Health, in regards to the grant of
intellectual property licenses and the use of federal authorities to end monopolies under the

KEI Nusinersen Patent Complaint, Page 2 of 22

REL0000023672.0001

Bayh-Dole Act. See, for example, our recent work on the exclusive licensing of federally
owned inventions by the National Institutes of Health, hite://keionline. org/nih-licenses . See
also our petition to the National Institutes of Health and the U.S. Army to use march-in rights
(35 U.S.C. § 203) or the government’s royalty-free license in the patents (35 U.S.C. §
202(c)(4)) on the prostate cancer drug Xtandi as a mechanism to lower the excessive price of
the drug in the United States, hite://kelionline.org/xtandi .

ll. Spinal Muscular Atrophy (SMA) and Nusinersen (Spinraza)

[1.A. Spinal Muscular Atrophy Incidence, Presentation, and Genetics

Spinal Muscular Atrophy (SMA) is a genetic neuromuscular disease that affects the nervous
system, in particular control of muscle movement.' The disease results in muscle weakness
and wasting, difficulty breathing, and paralysis.

SMA is the primary genetic cause of infant death.”
Current estimates for incidence range from 1 in 6,000 to 1 in 10,000 live births. Approximately
1 in 40 to 1 in 60 people carry the gene that contributes to the disorder. Because SMA is

recessive, both parents must carry the gene in order for the disease to present.

Clinicians classify SMA “into four phenotypes on the basis of age of onset and motor function
achieved.”°

The following table from D’Amico et al. shows the classifications:

Table Il.1: Classifications of Spinal Muscular Atrophy (SMA)

Po Age of Onset | Highest function achieved
Type | (Werdnig-Hoffmann disease) 0-6 months
Type Il (intermediate) 7-18 months /Sitnever stand /Sitnever stand stand

Type Ill (mild, Kugelberg-W elander > 18 months Stand and Walk during
disease) in adulthood adulthood

Type IV (adult) 2°-3° decade | Walk unaided

1 This section draws upon Adele D'AMico et al., Spinal Muscular Atrophy, 6 Orphanet J. Rare Diseases 71
(2011), unless otherwise stated.

2 Cure SMA, About SMA, http://www.curesma.org/sma/about-sma/.

3 D'Amico, Spinal Muscular Atrophy.

KEI Nusinersen Patent Complaint, Page 3 of 22

REL0000023672.0001

The most common form of SMA is Type |, causing severe symptoms and death, as D’Amico
et al. write:

SMA type 1 (Werdnig-Hoffmann disease) is the most severe and common type, which
accounts for about 50% of patients diagnosed with SMA. Classically infants with SMA
type | have onset of clinical signs before 6 months of age, never acquire the ability to
sit unsupported and, if no intervention is provided, generally do not survive beyond the
first 2 years. These patients have profound hypotonia, symmetrical flaccid paralysis,
and often no head control. Spontaneous motility is generally poor and antigravity
movements of limbs are not typically observed. In the most severe forms decreased
intrauterine movements suggest prenatal onset of the disease and present with severe
weakness and joint contractures at birth and has been labeled SMN 0. Some of these
children may show also congenital bone fractures and extremely thin ribs. (Citations
excluded.)

Everyone has two SMN genes, SMN1 and SMN2, to produce the SMN protein. In individuals
with SMA, the SMN1 gene is defective and cannot be used to produce SMN protein. They
must therefore rely solely on SMN2 gene to make the SMN protein. However, the SMN2 gene
is not as efficient at making full length SMN protein and does not produce enough of the
functional protein to make up for the loss of SMN1. This affects several cellular processes in
motor neurons resulting in their degeneration, causing the muscles under their control begin
to atrophy.’

[!.B. Nusinersen (Spinraza) Mechanism of Action and Efficacy

Nusinersen, marketed by Biogen under license from lonis Pharmaceuticals as Spinraza, is the
first treatment for pediatric and adult SMA approved for sale in the United States by the Food
and Drug Administration. °

The FDA approved nusinersen as a New Drug Application under Priority Review. In addition,
the FDA granted nusinersen Orphan Designation, which enabled Biogen to claim the
50-percent orphan drug tax credit on qualifying clinical trials, and affords Biogen seven years
of marketing exclusivity from the date of approval of the NDA.°

4 Saif Anmad et al., Molecular Mechanisms of Neurodegenerationin Spinal Muscular Atrophy, 10 J.
Experimental Neurosci. 39 (2016).

5 Biogen, U.S. FDA Approves Biogen’s SPINRAZA™ (nusinersen), The First Treatment for Spinal Muscular
Atrophy, Dec. 23, 2016,

nite. /media blocen cam/oress-reléase/neurodeqenérative-diseases/us-fda-anproves-bingens-soinraza-nusi

eived orphan designation on April 18, 2011. See the FDA database of Orphan Drug
Designations and Approvals, at

tatetersbentbadcessonsanscsnsastanbecssssrecacotatnanetouevcasseansnssenatetaterencelnduncnensnceerenasnsaeepssuecccesesesepucnecusnasseaseenldieneconccedbecancecsessnerasezercsnsanavensensnsnenscnecsscnentecctseceressussetiesshudacasesateentnenefbessascvaenenenensnenseat

KEI Nusinersen Patent Complaint, Page 4 of 22

REL0000023672.0001

The high price of nusinersen — $750,000 for the first year of treatment and $375,000 for
every year thereafter — generated significant controversy, as reported in FiercePharma:
“Regardless of how fair or reasonable Spinraza’s sticker might be in the ultra-orphan context,
however, the outsize price tag was guaranteed to raise eyebrows, given the close scrutiny
drug prices currently face.”’

As mentioned in the previous section, patients with SMA have a defective SMN1 gene, which
leaves their body with an insufficient amount of the SMN protein and causes the death of
motor neurons and muscular degeneration. Nusinersen acts on SMN2 unspliced mRNA
transcripts and helps it make full length functional SMN protein, thus compensating for the
malfunctioning SMN1 gene.

FDA approval of nusinersen was based on the interim results of a phase 3 double blind
randomized clinical trial, ENDEAR (NCT02865109), and phase 3 open-label clinical trial,
SHINE (NCT02594124).

ENDEAR enrolled 121 infants less than 7 months of age, and 82 were eligible for analysis at
the time. According to the FDA label, the primary endpoint measured was “improvement in
motor milestones according to Section 2 of the Hammersmith Infant Neurologic Exam
(HINE).” The analysis demonstrated “statistically significant improvements in motor
milestones, and the drug was generally well-tolerated, with a favorable safety profile and no
significant adverse events.”®

The SHINE study, conducted in patients 30 days to 15 years, supported the ENDEAR results,
such that, according to the FDA label, “some patients achieved milestones such as ability to
sit unassisted, stand, or walk when they would otherwise be unexpected to do so, maintained
milestones at ages when they would be expected to be lost, and survived to ages unexpected
considering the number of SMN2 gene copies of patients enrolled in the studies.”

phase III studies cited in the FDA label for nusinersen were conducted after the FDA granted orphan
designation, making them eligable for the orphan drug tax credit.

’ Tracy Staton, Biogen’s $375K Spinraza Price Puts a Sovaldi-Style Spotlight on Rare Disease Meds,
FiercePharma, Jan. 3, 2017,

nite /Avwwiiercepharmna com/oharma/biogens-375k-spinraza-price-
se-meds.

§ Carolina Henriques, Regulatory Applications for SMA Therapy Nusinersen Accepted in US and EU, SMA
News Today, Nov. 1, 2016,

nites -//smanewstoda ycom/20 16/11/0 t/regquiatory-applications-sma-iherap

uts-a-sovaldi-style-spotlicht-rare-disea

~Tusinersen-emepied-us-fda-eu-

erra.

KEI Nusinersen Patent Complaint, Page 5 of 22

REL0000023672.0001

lll. The Bayh-Dole Act and Disclosure of Subject Inventions

The Bayh-Dole Act and Federal regulations and guidelines make clear several obligations for
contractors in the disclosure of government rights in subject inventions, including: (1) a
requirement to disclose that federal funding contributed to an invention; (2) NIH contractual
requirements for disclosure; and (3) required language to be inserted in patent applications
and the patents, stating the role of federal funding and the government's rights.

First, contractors are required to disclose subject inventions discovered with federal funding in
a timely manner and with sufficient detail to describe the invention.

Under 35 U.S.C. § 202(c)(1), any contractor that receives funding from the federal
government is required to “disclose each subject invention to the Federal agency within a
reasonable time after it becomes known to contractor personnel responsible for the
administration of patent matters.”®

Under 37 C.F.R. § 401.3(a), each federal funding agreement shall contain the “standard
patent rights clause” found at 37 C.F.R. § 401.14(a), barring specific circumstances and
exceptions. '° Subsection (c)(1) of the patent rights clause outlines the disclosure
requirements, including a two month time limit on the disclosure of patents and a requirement
that the disclosure have sufficient detail:"

Fe R. .§ 4 401. 14(ayen)

c) Invention Decoses Election of Title and Filing of Patent Application by Contracto

on The contractor will disclose each Subject invention to the Federal Agency within

identify ihe contract under which the invention was ede and the inventor(s). It shall
be sufficiently complete in technical detail to convey a clear understanding to the extent
known at the time of the disclosure, of the nature, purpose, operation, and the physical,
chemical, biological or electrical characteristics of the invention. The disclosure shall ace :
identify any publication, on sale or public use of the invention and whether a manuscript
describing the invention has been submitted for publication and, if so, whether it has been
ped for publication at me time of Bese in adanon, ae disclosure to the agen

° The statute defines a “subject invention” at 35 U.S.C. § 201(e) as “any invention of the contractor
conceived or first actually reduced to practice in the performance of work under a funding agreement,” and
defines a contractor at 35 U.S.C. § 201(c) as “any person, small business firm, or nonprofit organization that
is party to a funding agreement.”

10 The exceptions do not contain reference to the disclosure requirements.

Italics in original.

KEI Nusinersen Patent Complaint, Page 6 of 22

REL0000023672.0001

Second, in implementing this regulation, the National Institutes of Health requires contractors
to disclose subject inventions via iEdison, an online electronic system for reporting inventions
and patents discovered under federal grants, and via HHS Form 568, entitled, “Final Invention
Statement and Certification (For Grant or Award),” available at:

nites: //orants nih cov/arants/hhsS68 odf .

The NIH specifies the required information on an FAQ related to the use of iEdison, and also
notes that contractors should disclose the subject invention even if they have, in the past,
failed to report the invention within the two month period:

hedison fags cirevillgaccessed Jan. 6, 2017).

KEI Nusinersen Patent Complaint, Page 7 of 22

REL0000023672.0001

ys report 4 the invention, even if it is late. ‘The invention report date soul Be the date
nventor notifi ed me awardee | institution of the a invention. Provide an | explanation

On February 17, 2016, NIH issued a notice entitled “Reminder: All Subject Inventions Must Be
Reported on the HHS 568 - Final Invention Statement and Certification (For Grant or Award)
and in iEdison.” The notice explained that failure to disclose the subject invention via both
iEdison and Form 568 could result in the loss of rights in the invention. '° As explained below
in section V on remedies, this notice is consistent with precedent related to failure to disclose.

Finally, under 35 U.S.C. § 202(c)(6) and 37 C.F.R. § 1.77(b)(3), contractors are required to
state within the patent application that the federal government contributed funding to support
the discovery of the invention and that the government retains certain rights:

Government support and oe

13 National Institutes of Health, Reminder: All Subject Inventions Must Be Reported on the HHS 568 - Final
Invention pevroele Wu pain (For Grant or Award) and in iEdison, NOT-OD-16-066 (Feb. 17, 2016),
j fnotice-Ties/NOFOD- 16-066 him

KEI Nusinersen Patent Complaint, Page 8 of 22

REL0000023672.0001

opment.

The Manual of Patent Examining Procedure contains the following recommended language:

“This invention was made with government support under (identify the contract)
awarded by (identify the Federal agency). The government has certain rights in the
invention.” *

IV. The Nusinersen Patent Landscape and Failure to Disclose Government Rights
in a Subject Invention

This section will outline the patent landscape for nusinersen and explain the failure of Isis
Pharmaceuticals to disclose federal funding in the work that contributed to the ’977 and ’853

patents, in violation of 35 U.S.C. § 202(c)(1).

lonis claimed five United States patents as the “key ... patents protecting nusinersen” in its
2015 Securities and Exchange Commission 10-K filing."

Table IV.1: Key United States Patents in Nusinersen

Priority {Filing Expiration Original
Patent No. | Title Date Date Date Assignee

ALTERATION OF

CELLULAR

BEHAVIOR BY Isis

MODULATION OF Oct. 7, Mar. 26, Pharmaceuticals,
6,210,892 |MRNA PROCESSING /|1998 1999 2018 Inc.

MPEP (9th ed. Rev. 07.2015, Nov. 2015), § 310.

8 flonis Pharm., Inc., Annual Report (Form 10-K), (Feb. 25, 2016). The Food and Drug Administration (FDA)
approved nusinersen for the treatment of spinal muscular atrophy based upon New Drug Application No.
209531 on December 23, 2016. Drugs@FDA Database. Due to the recent approval date, the patents for
nusinersen are not yet listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations,
known as the Orange Book.

KEI Nusinersen Patent Complaint, Page 9 of 22

REL0000023672.0001

SPINAL MUSCULAR

ATROPHY (SMA)

TREATMENT VIA

TARGETING OF

SMN2 SPLICE SITE

INHIBITORY Dec. 3, Dec. 5, University of
7,838,657 |SEQUENCES 2004 2005 2027 Massachusetts

SPINAL MUSCULAR

ATROPHY (SMA)

TREATMENT VIA

TARGETING OF

SMN2 SPLICE SITE

INHIBITORY Dec. 3, Aug. 21, University of
8,110,560 |SEQUENCES 2004 2009 2025 Massachusetts

COMPOSITIONS AND

METHODS FOR Isis

MODULATION OF June 23, |June 23, Pharmaceuticals,
8,361,977 |SMN2 SPLICING 2005 2006 2030 Inc.

COMPOSITIONS AND

METHODS FOR Isis

MODULATION OF Pharmaceuticals,

SMN2 SPLICING INA |June 17, |June 17, Inc.; Cold Spring
8,980,853 |SUBJECT 2009 2010 2030 Harbor Laboratory

We will not address the 892 patent, which is set to expire next year, nor will we address a
European patent that is identical to the 977 patent (European Patent No. 1910395).

IV.A. The University of Massachusetts Patents

The patents owned by the University of Massachusetts describe the composition (U.S. Patent
No. 7,838,657) and the method of use (8,110,560) of “oligonucleotide reagents (e.g.,
oligoribonucleotides) that effectively target the SMN2 ISS-N1 site in the SMN2 pre-mRNA,
thereby modulating the splicing of SMN2 pre-mRNA to include exon 7 in the processed
transcript.”

The laboratory of Dr. Ravindra N. Singh invented the ‘657 and ’560 patents in the course of
research on the “molecular basis of Spinal Muscular Atrophy.””®°

KEI Nusinersen Patent Complaint, Page 10 of 22

REL0000023672.0001

The patents list Dr. Ravindra N. Singh, Dr. Natalia N. Singh, Dr. Nirmal K. Singh, and Dr. Elliot
J. Androphy as inventors.

Both patents acknowledge federal funding from the National Institutes of Health in support of
the work described in the patent, and also acknowledge the government’s retained rights:

Funding for the work described herein was at least in part provided by the federal
government (N.I.H. grant RO1 NS40275). The government may, therefore, have certain
rights in the invention.

The NIH awarded grant RO1 NS40275 to Dr. Elliot J. Androphy, who at the time of the
discovery of the invention directed the joint M.D./Ph.D. program at the University of
Massachusetts Medical School."”

The University of Massachusetts licensed the patents to Isis Pharmaceuticals on January 14,
2010."

KEI has requested additional information on the research and resulting intellectual property
from the University of Massachusetts through a request under the Massachusetts Public
Records Law, Mass. Gen. Laws ch. 66, §10 (2017).

IV.B. The ’977 and ’853 Patents: Failure to Disclose Government Rights in the
Patents

The ’977 and ’853 Patents are, respectively, a compound patent and method of use patent for
nusinersen as a treatment for SMA. We believe that Isis Pharmaceuticals and Cold Spring
Harbor Laboratory failed to disclose that the inventions in the patents are subject inventions
under the Bayh-Dole Act, as required by 35 U.S.C. § 202(c)(1).

The ’977 patent is assigned to Isis Pharmaceuticals, and was invented by employees of Isis
and Cold Spring Harbor Laboratory, a nonprofit research laboratory located on Long Island in
New York. The inventor Brenda F. Baker was at the time of the patent application filing date
employed by Isis, while Adrian R. Krainer was a Professor at Cold Spring Harbor Laboratory,
and Yimin Hua was a Postdoctoral Fellow and later a Research Investigator at Cold Spring
Harbor Laboratory. Before joining Cold Spring Harbor Laboratory in July 2004, Yimin Hua
was a postdoctoral fellow at Tufts and the University of Massachusetts, studying SMA/SMN. '°

1? See the NIH REPORTER database for additional information on the UMass grants:
nitos:/projectreportemin gov/Reporter Vewsh cim?si= 12ZEBCDOF4888C 403 7 S98BS90 1 CAAIADLACEECE

*® UMass Agreement No: UMMS 05-19-03,
nites /Amansec cov/Archives/ecqaridata/S 74) 15/00008 74015 1400009S/ex10 Lhim

9 https://wwwiinkedin.com/in/yimin-hua-6b58956

KE] Nusinersen Patent Complaint, Page 11 of 22

REL0000023672.0001

The ’853 patent is assigned to both Isis and Cold Spring, and lists amongst its inventors
employees of Isis, Genzyme, and Cold Spring Harbor:”°

e C. Frank Bennett — Isis Senior Vice President for Research

e Gene Hung — Isis

e Frank Rigo — Isis

e Adrian R. Krainer — Professor, Cold Spring Harbor Lab

e Yimin Hua — Postdoctoral Fellow and Research Investigator, Cold Spring Harbor Lab
e Marco A. Passini — Researcher, Genzyme

@ Lamya Shihabuddin — Senior Director, Genzyme

e Seng H. Cheng — Group Vice President, Genetic Diseases Science, Genzyme

e Katherine W. Klinger — Senior Vice President, Genetics and Genomics, Genzyme

A news story published in October 2016 in Nature Biotechnology describes how the
collaboration between Isis and Dr. Krainer of Cold Spring Harbor came about:

“The one-nucleotide change that causes SMN2 to skip an exon prevents a splicing
activator from binding. Krainer began experimenting with a peptide designed to trigger
the splicing of SMN2 exon 7 and its inclusion in the SMN2 pre-mRNA, thus creating a
full-length, stable SMN2 protein. He linked an antisense molecule to the peptide
just to direct it to the correct region on SMN2, but to Krainer’s surprise the
antisense alone was able to correct the splicing defect, although not as potently.
“An important and lucky observation,” says Krainer. “We didn’t expect it, and we
didn’t initially understand it.” Upon publication of the finding, lonis contacted
Krainer and began collaborating with him (Nat. Struct. Biol. 10, 120-125, 2003).

“lonis brought its antisense technology to the table. The company’s 2'-O-meth oxyethyl
(2'MOE) phosphorothioate chemistry, with sulfur substituting for one of the
non-bridging oxygen atoms in the phosphate backbone, and chemical modification of
the sugar at the 2' position, helps resist nuclease degradation and enhances cell
penetration. It thus was an excellent in vivo splicing modifier. Krainer and Isis
screened over 500 different antisense molecules against various sites on SMN2
exon 7 and its adjacent introns. The best at splicing exon 7 into the SMN2
pre-mRNA was nusinersen, an 18-nucleotide antisense oligo that blocks the
intronic binding site of a splicing repressor. Because nusinersen binds a unique
sequence, it shouldn’t have off-target effects, says Krainer, and because the target is
on an intron that’s spliced out of the protein, the drug comes off and doesn’t interfere
with SMN2 translation. Blocking this single site is enough for the drug to achieve up to

20 All employments listed below indicate employmentat the time that the patent application for the '853
patent was filed.

KEI Nusinersen Patent Complaint, Page 12 of 22

REL0000023672.0001

90% exon 7 inclusion in SMN2 transgenic mice (Am. J. Hum. Gen. 82, 834-848,
2008). Human trials began in 2011.”*"

Dr. Krainer published his initial findings (the first finding described above in the Nature
Biotechnology story, that we should target SMN2 to treat SMA) in 2003 in Nature Structural
Biology with Dr. Luca Cartegni, then a Post-Doc at Cold Spring Harbor:

e Luca Cartegni and Adrian R. Krainer, Correction of Disease-Associated Exon Skipping
by Synthetic Exon-Specific Activators, 10 Nature Structural Biology 120-125 (2003).

In the acknowledgements section, Dr. Cartegni and Dr. Krainer acknowledged support from
the National Institutes of Health, without providing a particular grant number. Cartegni and
Krainer, 125.

In 2008, Dr. Krainer and members of his lab co-authored a paper with C. Frank Bennett and
Timothy A. Vickers of Isis Pharmaceuticals identifying the sequence for nusinersen:

e Yimin Hua, Timothy A. Vickers, Hazeem L. Okunola, C. Frank Bennett & Adrian R.
Krainer, Antisense Masking of an hnRNP A1/A2 Intronic Splicing Silence Corrects
SMN2 Splicing in Transgenic Mice, 82 Am. J. Human Genetics 834-848 (2008).

The acknowledgements in this paper also cited NIH funding, this time providing a particular
grant number:

"We thank Chaolin Zhang for help with hnRNP A1 PWM analysis and Xavier Roca and
Michelle Hastings for useful comments on the manuscript. We also thank A. Burghes
for helpful discussions. Y.H. and A.R.K. gratefully acknowledge support for this work
from the SMA Foundation, the Muscular Dystrophy Association, the Louis Morin
Charitable Trust, and National Institutes of Health grant GM42699. T.A.V. and C.F.B.
are employees of Isis Pharmaceutical, the owner of the antisense oligonucleotide
chemistry used in this report, and materially benefit either directly or indirectly through
stock options. Y.H. and A.R.K., along with their employer, Cold Spring Harbor
Laboratory, could materially benefit if a therapeutic for SMA results from this work.
A.R.K. serves on the scientific advisory board of two nonprofit SMA foundations.” *”

The NIH RePORTER database shows that Dr. Krainer has received funding from the NIH
under grant number GM42699 since at least 1993 (the earliest date in the database).
Between 2006 and 2007 (the year in which the paper was submitted to the journal), Dr.
Krainer received $1,175,935 in funding under the grant. Over the course of the past 23 years,

21 Ken Garber, Big Win Possible for lonis/Biogen Antisense Drug in Muscular Atrophy, 34 Nature Biotech.
1002, 100 (2016) (emphasis added).
2 Hua et al., 846 (emphasis added).

KEI Nusinersen Patent Complaint, Page 13 of 22

REL0000023672.0001

Dr. Krainer has received $11,701,483 in funding under this grant. See Appendix | for
additional information on Dr. Krainer’s grants.

We have a high degree of confidence that the Krainer grants contributed directly to the
reduction of practice of nusinersen as a treatment for SMA because of the federal funding
acknowledged in the paper and the overlap between the findings described in the paper and
the patent.

Figure IV.1: Timeline of Publications , Collaborations, and Patent Filings/Grants

200: isis and Dr. Adan R. Krainer at Gaki

Spring Marber Laboratory begin ta collaborate Jkune 23, 2008: Filing date Jan. 29, 2043 and Mar. 17,
after fir. Krainer publishes. @ paper on targeting of for 877 and ‘853 pate ‘i 2078 USPTO grants the
the SMN2 gene for the treatment of SMA. Ee ‘O?? and ‘853 patents.

dune 23, 2005: Priority date 2007-2008: Oe. Kreiner and isis subst
for S77 and 853 oaterts. and publish an article armouncing the
diacovery of nusinersen as a treatment

for SMA in the American Journal of
Human Ganetics.

The above timeline of events shows that Isis and Dr. Krainer started their collaboration shortly
after Dr. Krainer published his 2003 paper, which benefitted from public funding. The research
that led to the discovery of nusinersen as a treatment for SMA, then, was conducted between
2003 and 2005 — the priority date listed on both the 977 and ’853 patents. Shortly after the
patent filing date of June 23, 2006, Isis and Dr. Krainer likely began work on drafting their
paper, which was submitted in 2007 and accepted for publication in 2008. The paper, as
stated previously, acknowledged that NIH funding contributed to the research to discover that
nusinersen could be used as a treatment for SMA.

Dr. Krainer and colleagues identified the antisense oligonucleotide (ASO) that would best
correct SMN2 splicing in their 2008 American Journal of Human Genetics publication:

“After elucidating the exact position and mechanism of the intron 7 ISS, we optimized
the most potent ASOs that target this silencer and used them to try to rescue SMN2
splicing in mice harboring a human SMN2 transgene. First, we synthesized 38 ASOs of
different lengths and examined their effects on splicing of transcripts of the
endogenous SMN2 gene in HEK293 cells.””°

3 Yimin Hua, Timothy A. Vickers, HazeemL. Okunola, C. Frank Bennett & Adrian R. Krainer, Antisense
Masking of an hnRNP A1/A2 Intronic Splicing Silence Corrects SMN2 Splicing in Transgenic Mice, 82 Am. J.
Human Genetics 834, 842-3 (2008).

KE]! Nusinersen Patent Complaint, Page 14 of 22

REL0000023672.0001

They found that ASO 10-27 and 09-23 were the best candidates for further testing in
transgenic mice. Ultimately, the ASO 10-27 sequence was chosen for nusinersen.

ASO 10-27 is the same as the gene sequence for nusinersen as listed in the 977 and ’853
patents.

The ’853 patent claims the following:

1. Amethod comprising administering by a bolus injection into the intrathecal space of
a subject with infantile-onset type | spinal muscular atrophy (SMA) an antisense
compound comprising an antisense oligonucleotide consisting of 18 linked
nucleosides, wherein the oligonucleotide has a nucleobase sequence consisting of the
nucleobase sequence SEQ ID NO: 1, wherein each internucleoside linkage of the
oligonucleotide is a phosphorothioate linkage, wherein each nucleoside of the
oligonucleotide is a 2-MOE nucleoside, and wherein the administering of the
antisense compound ameliorates at least one symptom of SMA in the subject.

2. The method of claim 1, wherein the antisense compound is administered at a
dose from 0.5 to 10 milligrams of antisense compound per kilogram of body

weight of the subject.

3. The method of claim 1, wherein inclusion of exon 7 of SMN2 mRNA in a
motoneuron in the subject is increased.

4. The method of claim 1, wherein a 5 mg to 20 mg dose of antisense is
administered.

SEQ ID NO: 1, as described in claim 1, is the following: TCACTTTCATAATGCTGG.

The 2008 collaborative paper published by Cold Spring Harbor and Isis, which benefitted from
federal funding, also identifies sequence number 1 in Table 1, as ASO 10-27:

KEI Nusinersen Patent Complaint, Page 15 of 22

REL0000023672.0001

Sicvoeaik tn Intven 7°

R-25 SUALTITESTAATECIGGCA- 6 ta SS

8-36 THCATAARATOR-3° 3 ha 26

Wei Be ibe 2
Yi-2R —-4§- TECACTITEATAATOCTG-3° 1 to 28
ER-BS SUAPICACT TIA ESA T-3° 15 ty 2S
16-23S S-TRCALTITICATA AI -3 48 te 88
E3-27 SU-TCALTYICATAST-3° 43 te 27
2-26 5) LACT ILATAARR TF 1é te 26
I-24 SULTYLST AAT OES G-3° 16 ty 24
4-33 8 -TERLATAATALTOGL- 3° a ba 23

RA-7E SUTRCATAATECIOGUA-3° 6 ta 82

OY-24 5" TEATSATORTGHIAR-2 ¥ ta SE

2-25 S_ATIWACTTICAT- 2 18 te 29
Ly=28 0S -TREACTITCATA-3° 1¥ to 28
16-27 a TEACTTICATAS-3° 18 te 27
18-26 5 CUCTTIATAA E23" 18 te 26
4-25 S-SETITES TART G-3" 14 te 25
ER-Za SCP TTCATAATOC-2 1S te 24
22-23 5°. TRRATAARRT-3 LF te 23

The ’853 patent makes the link explicit by citing the 2008 paper.

The ’977 patent also relied on the research from the Cold Spring Harbor/Isis collaboration,
similarly identifying the sequence in the first claim of the ’853 patent.

IV.B.1 Federal grants to ISIS Pharmaceuticals

Isis has also received federal funding for its work on antisense-based drugs, which may have
contributed to the research on the development of nusinersen.™ For example, project number
1R43GM058974-01 describes the development of antisense oligonucleotides, with the
following proposed commercial applications:

“Therapeutic antisense oligonucleotides are potentially a multibillion-dollar industry.
Commercialization of antisense oligonucleotides against viral, cellular and cancer
targets is limited by the pharmacokinetic and pharmcodynamic properties of existing
first generation 2'-deoxy phosphorothioate drugs. RNA modifications which enhance
target affinity and biostability can lead to antisense drugs of (i) shorter length (which
translates to improved absorption and lower production cost), and (ii) less frequent
dosing, and (iii) higher target specificity, and hence less toxicity.””°

Overall, the NIH has provided Isis with at least $17,509,977 in total funding since 1993.
Between 2003 and 2006, the period that nusinersen was in development, Isis received
$10,821,633 in grants from DHHS, not including grants received from the US Army and

4 See Appendix | for additional information on the Isis grants.
25

nites -//orojectreportemih covioroiect info description cim?aid=27o2e6568icce=32525007 dddparam=addval
Je=gcddsub=Scr=2hSesh=adefaulthcs=ASCanball=

KEI Nusinersen Patent Complaint, Page 16 of 22

REL0000023672.0001

DARPA. In general, however, the NIH funding to Cold Spring Harbor Laboratory is the most
direct and compelling evidence regarding the federal funding of the inventions.

V. Remedies

In addition to investigating the above evidence related to the possibility that Isis failed to
disclose subject inventions, the Office of the Inspector General should explore relevant
remedies to rectify the alleged failure to disclose the subject inventions in the 977 and ’853
patents.

In particular, failure to disclose subject inventions pursuant to 35 U.S.C. § 202(c)(1) permits

the Federal Government to “receive title to any subject invention not disclosed to it
within such time” (emphasis added).

in the past, the Federal Government has utilized its authority to claim title in subject inventions
that have not been properly disclosed, as in the case of Campbell Plastics Engineering &
Mfg., Inc. v. Brownlee, 389 F.3d 1243 (Fed. Cir. 2004) (finding that federal government claim
of title in invention was legitimate under federal acquisition regulations and supported by the
Bayh Dole Act where disclosure submissions were “piecemeal” and violated the contractual
agreement with the government); see a/so Central Admixture Pharmacy Services, Inc. v.
Advanced Cardiac Solutions, P.C., 482 F.3d 1347, 1352-53 (Fed. Cir. 2007) (“Critically,
Campbell Plastics holds that a Bayh—Dole violation grants the government discretionary
authority to take title. ... When a violation occurs, the government can choose to take action;
thus, title to the patent may be voidable.”).

In Campbell Plastics, the court found that the contract was clear and unambiguous, but
moreover the government's claim to title was “buttressed by the policy considerations behind
the Bayh Dole Act.” /d. at 1248. These include, specifically under 35 U.S.C. § 200, the need
“to ensure that the Government obtains sufficient rights in federally supported inventions to
meet the needs of the Government and protect the public against nonuse or unreasonable
use of inventions.”

VI. Concluding Comments

On behalf of patients, taxpayers, employers and everyone who pays for health care, we ask
your office to investigate whether Isis and/or Cold Spring Harbor failed to comply with the
provisions of the Bayh-Dole Act requiring the disclosure of federal funding in patents related

to nusinersen.

We also ask your office to investigate whether the National Institutes of Health failed to
conduct proper oversight in administering its grants.

KEI Nusinersen Patent Complaint, Page 17 of 22

REL0000023672.0001

Finally, we ask you to recommend appropriate action to remedy the situation in line with the
statute and prior decisions with regard to failure to disclose a subject invention.

The failure to disclose federal funding in nusinersen is significant because it affects the
disposition of the federal government's rights to end the patent monopoly and authorize
generic manufacture under the march-in provisions and government royalty-free right in the
Bayh-Dole Act.

KEI and other public interest groups have asked the government to use those rights to lower
the excessive price of pharmaceuticals in the past. (See hitto://keionline org/xtandi). We intend
to ask the NIH to initiate a march-in case for the federally-funded patents on nusinersen over
the excessive price ($750,000 in the first year and $375,000 per year thereafter for
maintenance doses), and also to ask Medicare or other federal agencies to use their royalty
free rights in the drug to authorize the manufacture and sale of generic versions of the drug at
reasonable prices. We believe the Trump administration will take a different view than the
Obama Administration on the issue of charging excessive prices on federally funded medical
inventions.

We recognize that nusinersen benefits from non-patent exclusivities, including Orphan Drug
exclusivity and exclusive rights in test data. However, Congress is likely to consider
exceptions to such exclusivity in the coming years, and in any event, the patent term exceeds
any non-patent exclusivities. Resolving access to the federally-funded inventions via march-in
or the royalty free right provides the federal government with much greater leverage to lower
the price of this treatment for a very severe disease.

We would like to meet with you and your staff to discuss how we can assist you in moving
forward with an investigation.

Sincerely Yours,

James Love, Director
Knowledge Ecology International

Andrew Goldman, Legal Counsel
Knowledge Ecology International

Zack Struver, Research Associate
Knowledge Ecology International

Diane Singhroy, Scientific Advisor
Knowledge Ecology International

CC: Gary Cantrell, Deputy Inspector General for Investigations, Gary.Cantrell@oig.hhs.gov

KEI Nusinersen Patent Complaint, Page 18 of 22

REL0000023672.0001

Appendix I: Information on Misc Grants

1. Adrian R. Krainer/Cold Spring Harbor Laboratory Grant No. GM42699

For additional information, see the following query results from the NIH REPORTER database:
https //oroiectreporier nih.gov/Reporter Viewsh. .cim?si= 1 2E BC DOS4889C4 Dr 7S598RBR961 CA
ASADIAZFFCEBSCIBE

Dr. Krainer’s grants for the project entitled “Biochemistry of Pre-mRNA Splicing” are
administered by the National Institute of General Medical Sciences (NIGMS).

KEI Nusinersen Patent Complaint, Page 19 of 22

REL0000023672.0001

2. Isis Pharmaceuticals’ Grants from RePORTER query

For additional information, see the following query results from the NIH REPORTER database:

ASADTAZFECEBSOIBE

Isis Pharmaceuticals’ grants are administered by various components of the National
Institutes of Health, or the CDC, under several different grant numbers.

Project Title IC

ANTISENSE INHIBITORS OF
HERPES SIMPLEX VIRUS

REPLICATION NIAID
OLIGONUCLEOTIDES AS
INHIBITORS OF

PAPILLOMAVIRUSES NCI

Project Number

-2R44A1030331-02

-2R44CA052391-02

Contact PI / Project
Leader

“ANDERSON, KEVIN P

‘COWSERT, LEX

» 1993 |

FY Total.

$193,250 -

$118,544

ANTISENSE INHIBITORS OF
-HERPES SIMPLEX VIRUS

REPLICATION NIAID
S' CAP--A NOVEL TARGET

FOR ANTISENSE
» TECHNOLOGY NIAID

-SYNTHETIC MRNA CLEAVING

AGENTS NIGMS |

-OLIGONUCLEOTIDES AS
INHIBITORS OF
-PAPILLOMAVIRUSES NCI

-3' CAP--A NOVEL TARGET
»-FOR ANTISENSE
/ TECHNOLOGY NIAID

5R44A1030331-03

-2R44A1030333-02A1

5R44CA052391-03

: 5R44A1030333-03

ANDERSON, KEVIN P

BAKER, BRENDAF

“COWSERT, LEX M

BAKER, BRENDA F

1994

1994

$223,920 :
_$100 900)
$246,302 |

$253,349 |

“OLIGONUCLEOTIDES AS
INHIBITORS OF
»PAPILLOMAVIRUSES NCI

ANTISENSE INHIBITION OF
-MULTIDRUG RESISTANCE IN

CANCER NCI
“SYNTHESIS AND SELECTION

OF PLA2 INHIBITORS NIAMS

UTILITY OF CARBOCYCLIC
‘'NUCLEOSIDES FOR
ANTISENSE THERAPY NCI

5R44CA052391-04

:1R41CA068790-01

, 1R43CA074636-01

‘COWSERT, LEX M

: DEAN, NICHOLAS M

1R43AR043034-01A1 WYATT, JACQUELINE R

GRIFFEY, RICHARD H ©

» 1995

» 1995 ©

1995 |

$127,758 |

$99,865 |

$99,732.

1997 $100,000.

KEI Nusinersen Patent Complaint, Page 20 of 22

REL0000023672.0001

TARGETING AN ESSENTIAL
-METHYLASE IN PATHOGENIC
‘BACTERIA

TARGETING RHO--A
“TRANSCRIPTION
TERMINATION FACTOR

1R41A1041775-01A1

1R43A1043102-01

BLYN, LAWRENCE B

BLYN, LAWRENCE B

1998

$99,939

$100,000.

UTILITY OF CARBOCYCLIC
_NUCLEOSIDES FOR
“ANTISENSE THERAPY

L11/23S RRNA
INTERACTION--ANTIMICROBI
‘AL DRUG DEVELOPMENT

NCI

-1R43A1045210-01

3R43CA074636-01S1 |

GRIFFEY, RICHARD H

BLYN, LAWRENCE B

1998

$90,000

$100,000.

DISRUPTION OF
-EUBACTERIAL 4.5S RNA -P48
‘COMPLEX

“TARGETING 4.55 RNA
“ANTIMICROBIAL DRUG
_ DISCOVERY

ANTISENSE THERAPY USING
‘NOVEL RNA MIMETICS

OLIGONUCLEOTIDES FOR _
DIRECTED GENE KNOCKOUT

-ORAL ANTISENSE THERAPY
»-FOR CANCER

‘ANOVELANTICANCER

“STRATEGY

‘COMBINATORIAL
CARBOHYDRATE LIBRARIES
FOR DRUG DISCOVERY

ANTIMICROBIAL AGENTS
‘DIRECTED AGAINST L11/23S
/>RRNA

“ANTIMICROBIAL AGENTS
‘DIRECTED AGAINST L11/23S
-RRNA

“AUTOMATED SIMULTANEOUS |
DETECTION OF
BIOTERRORISM AGENTS

NCI

NIAID

NIAID

-1R41A1044515-01

-41R41A1050406-01
-2R44A1045210-02A1
/5R44A1045210-03

-1R01C1000099-01

JAMES, THOMAS L

-MANOHARAN,
-1R43GM058974-01 = MUTHIAH
‘MANOHARAN,
-1R43GM060087-01 = MUTHIAH
-MANOHARAN,
-1R41CA083543-01 — MUTHIAH

~ SAMPATH,
-4R43CA083601-01A1 |

RANGARAJAN

GRIFFEY, RICHARD H
“SWAYZE, ERIC E

“SWAYZE, ERIC E

-ECKER, DAVID J

“AUTOMATED SIMULTANEOUS
‘DETECTION OF
‘BIOTERRORISM AGENTS

‘SINGLE WELL MPCR DONOR
SCREEN TO ID BLOOD
PATHOGENS

CID

5R01C/000099-02

1R43HLO76946-01

2001

2004

$100,000 -
$140,000

$224,700

$100,000

$100,000.

$265,000.

$375,000 |

$2,313,198

$94,040

KE]! Nusinersen Patent Complaint, Page 21 of 22

REL0000023672.0001

PATHOGEN DIAGNOSTIC
‘_PRODUCTS--BIODEFENSE
DEVELOPMENTS NIAID -1UC1A1067232-01 BLYN, LAWRENCE B

“AUTOMATED SIMULTANEOUS
‘DETECTION OF
_BIOTERRORISM AGENTS CID —_- 5RO1C1000099-03 = ECKER, DAVID J

2005

2005

$4,649,863

$1,036,103

»CHEMICAL MODIFICATION TO
IMPROVE SIRNA

_PHARMACOKINETICS IN | |
“ANIMALS NIGMS 1R43GM076793-01 SWAYZE, ERICE 2006 = $99,187,
IDENTIFICATION OF AN : 2 2
INHIBITOR OF MICRORNA-122 | 2 2
IN LIVER NIAID 1R43A1072802-01 FREIER,SUSANM. 2007 $299,390
CHEMICAL MODIFICATIONS | |
‘TO IMPROVE RNAIDRUGS —NIGMS.__2R44GM076793-02 SWAYZE, ERIC E 2007 $482,643.
IDENTIFICATION OF AN

INHIBITOR OF MICRORNA-122 : :
IN LIVER NIAID 5R43A1072802-02 FREIER,SUSANM. 2008S $132,885.
‘CHEMICAL MODIFICATIONS : | 2 bee
‘TO IMPROVE RNAIDRUGS NIGMS 5R44GM076793-03 SWAYZE, ERIC E 2008 $464,156.
‘ASSESSING THE SAFETY OF _ - a
CELL SUBSTRATES AND 'SAMPATH,
VACCINE COMPONENTS NIAID NO1AI40100-5-0-1 RANGARAJAN 2009 $621,848.
‘CHEMICAL MODIFICATIONS : 2 | :
‘TO IMPROVE RNAIDRUGS —- NIGMS 5R44GM076793-04 SWAYZE, ERIC E 2009 «=: $463,365.

“ASSESSING THE SAFETY OF
CELL SUBSTRATES AND -SAMPATH,
“VACCINE COMPONENTS NIAID = N01A140100-6-0-1 » RANGARAJAN

3. Selected DoD Army and DARPA SBIR and STTR grants

$500,000 -

Grant title ‘Agency Type Year Amount
CERoC ei - aioe oe : ha laitten
Engineered Microbes DoD, Army SBIR 2005 = $119,663
TIGER Biosensor for Broad Viral Detection and Genetically :
Engineered Microbes DoD, Army SBIR 2007 == $728,422
Chee ee Gory ee Come a Sb i

KEI Nusinersen Patent Complaint, Page 22 of 22

REL0000023672.0001

From: Hammersla, Ann (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/CN=RECIPIENTS/CN=HAMMERSLAA]
Sent: 3/14/2017 3:39:41 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]

Subject: RE: Anyone have objection from KEI in 2017

KEI has made public statements that it is objecting to all grants of exclusive licenses and that it does
not have enough information to analyze whether NIH is making a good decision re the license and royalties

weeee Original Message-----

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, March 14, 2017 11:22 AM

To: Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>
Subject: Re: Anyone have objection from KEI in 2017

I was asking in general about IRP notices of intent to grant. KEI objected to nearly every notice of
exclusive licenses from the IRP last year, and asked for our justification under the statutory criteria
for granting the exclusive.

Sent from my iPhone

On Mar 14, 2017, at 10:29 AM, Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov> wrote:

I am not familiar with this FR notice. I will check. When was the FR notice? Ann

VVVVV

v

----- Original Message-----

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, March 13, 2017 5:00 PM

To: NIH TDC Long <niaaatdcl-1@mail.nih.gov>
Subject: Anyone have objection from KEI in 2017

From FR notice of intent to grant?

Thx
Mark

VVVVVVVVVVV

Sent from my iPhone

REL0000023673

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]

Sent: 8/25/2019 11:46:33 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkley, Dale (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]

cc: Goldstein, Bruce (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cb67e8fe5aa2452a8a7f200e5fb4335b-goldsteb]; Pazman, Cecilia
(NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]

Subject: Emailing: KEl Comments NIH License to MTTI Described in 84 FR 39001_.pdf, NIHtoKEI re MTT! 25Aug2019.docx

Attachments: KEI Comments NIH License to MTTI Described in 84 FR 39001_.pdf; NIHtoKE! re MTTI 25Aug2019.docx

Dale and Mark -- a pdf with KEI's comments (received Aug 23) and a word doc with my response enclosed.
Please have a look at both and let me know if you have any comments or edits to the response.

Thanks again!

Regards,

Michael A. Shmilovich, Esq., CLP

office of Technology Transfer and Development
31 Center Drive Room 4A29, MSC2479

Bethesda, MD 20892-2479

o. 301.435.5019

shmi lovm@mail.nih. gov

This message may contain privileged and confidential information intended only for the use of the
individual(s) or entity named above. If you are not the intended recipient, you are hereby notified that
any use, dissemination, distribution, or copying of this message or its content is strictly prohibited.

If you have received this message in error, please notify sender immediately and destroy the message
without making a copy. Thank you.

“Always be yourself....unless you can be a pyrate... then; obviously, be a pyrate”

Your message is ready to be sent with the following file or link attachments:

KEI Comments NIH License to MTTI Described in 84 FR 39001_.pdf
NIHtoKEI re MTTI 25Aug2019.docx

Note: To protect against computer viruses, e-mail programs may prevent sending or receiving certain types
of file attachments. Check your e-mail security settings to determine how attachments are handled.

REL0000023675

KNOWLEDGE ECOLOGY
INTERNATIONAL

1621 Connecticut Avenue NW
Suite 500
Washington, DC 20009
www.keionline.org
August 23, 2019

Michael Shmilovich, Esq.

Senior Licensing and Patent Manager
National Heart, Lung, and Blood Institute
31 Center Drive

Bethesda, MD 20892

Re: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that
Overexpress Integrin avB3, 84 FR 39001

Dear Mr. Shmilovich:

Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT)
are writing to comment on the prospective grant of an exclusive patent license in “a
radiotherapeutic against cancers that overexpress integrin av63” to Molecular Targeting
Technologies, Inc. (MTTI), as referenced in the notice located at 84 FR 39001.

The 84 FR 39001 notice is the third time since 2018 that the NIH has published a notice
concerning an exclusive license with MTTI in the same patent family, but it adds a new field of
use.

The previous exclusive license and a proposed amendment between the NIH and MTTI for
Lutetium-177 technologies were:

e The prospective license noticed on July 27, 2018 (83 FR 35663), which described a
prospective exclusive license to MTTI in “Radiotherapeutics Against
Somatostatin-Receptor Expressing Neuroendocrine Tumors,” and

e A prospective amendment to the 2018 license noticed on June 17, 2019 (84 FR 28063),
for “Lutetium-177 Radiotherapeutics Against Somatostatin-Receptor Expressing
Neuroendocrine Tumors.”

REL0000023675.0001

KEI filed comments in both of these cases, and copies of those comments are available here:
httos //www. Keionline ora/nih-licenses. The July 2, 2019 comments were filed jointly with the
Union for Affordable Cancer Treatment (UACT), and three individuals in their personal capacity,
James Love, Manon Ress and Luis Gil Abinader. We ask that the comments regarding the
earlier licenses be included in the record for this license, by reference, and also that the
suggestions for safeguards in that license that were set forth in the July 2, 2019 comments be
considered here for the new license (see below).

The Subject Invention and Patent Estate
Thank you for answering several of our questions about this new license.

Per your answers, it is our understanding that the original licensing opportunity was published in
2015 and updated in 2016, as “early stage.”

Long Acting Therapeutic Conjugates with Evans Blue

The licensing opportunity notice describes the patent estate as “a platform technology that
pertains to the advantages of conjugating therapeutics to Evans Blue thus providing long lasting
pharmacokinetic profiles by complexing with albumin.”

You have described this as a new license that expands the field of use for the same patent
estate identified in 84 FR 28063. In your August 23, 2019 email, you compare the new license
to the previous MTTI/lu-177 license and its proposed amendment as follows:

The fields of use and cancer targets are different. The targeting moiety in the previous
field of use licensed to the company is tetraazacyclododecanetetraacetic acid-octreotide
(TATE) which binds to somatostatin receptor present on neuroendocrine tumors. The
targeting moiety in the instant contemplated field is the RGD peptide
arginylglycylaspartic acid which binds to integrin avB3 that is overexpressed on a variety
of different cancers; however, the present field of use would be limited to only
glioblastoma multiforme and small cell lung cancers.

In the event that the NIH decides to grant this exclusive license, we ask that safeguards be

placed on the license to protect the public from (a) unreasonable pricing, (b) excessive terms of
exclusivity, (c) to address access in developing countries, and (d) to enhance transparency. Our
specific suggestions for safeguards are listed below, following further discussion of the licensee.

MTTI

Molecular Targeting Technologies, Inc. (MTTI) appears to be a small privately held firm with few
employees of its own, that has considerable success in obtaining NIH grants, either directly or

Page 2 of 7

REL0000023675.0001

indirectly through non-profit institutions. According to the NIH REPORTER database, MTTI has
received funding from the FDA and/or the NIH every year since 1998.

Table 1: NIH RePORTER figures for MTTI grant funding by fiscal year

Fiscal Year Projects Total Funding
1995 1 $98,500
1998 1 $100,000
1999 1 $134,600
2000 1 $100,000
2001 1 $372,700
2002 2 $727,300
2003 2 $513,688
2004 1 $335,239
2005 1 $418,825
2006 2 $891,387
2007 3 $1,853,974
2008 3 $1,732,733
2009 6 $1,891,013
2010 2 $572,812
2011 1 $414,018
2012 3 $1,457,619
2013 2 $1,078,417
2014 2 $1,055,660
2015 1 $224,819
2017 2 $514,163
2018 2 $279,610
2019 2 $608,921
Total 42 $15,375,998

MTTI has also benefited from NIH grants to other institutions. For example, MTTI has received
NIH funds through grants to Thomas Jefferson University and other research institutions.

Of the eight projects, seven report funding from the NIH. The only project without NIH funding
reports funding from the government of Taiwan.

NAME: Rabies mAb NAME: ZAPS SN-38
IP: MTTI licensed from the Thomas Jefferson University | INDICATION: Cancer
North China Pharmaceutical Company (NCPC) is STAGE OF DEVELOPMENT: Phase | clinical planned

initiating the phase III clinical trial in China in 2018. by Taivex Pharmaceutical in 2019.
PARTNER : MTTI sublicensed the product to North PARTNER: National Health Research Institutes (NHRI,
China Pharmaceutical Company in exchange for future | Taiwan) for preclinical studies.

Page 3 of 7

REL0000023675.0001

royalty stream. NCPC is responsible for all clinical
development costs.

IP: MTTI licensed from the Thomas Jefferson University
FUNDING: $425,000 from USDA (2006); $918,000 from
NIH (2007).

OWNERSHIP: MTTI shares co-exclusive rights in China
with Johnson & Johnson (previously Crucell).

Liaw

F
CORIO OTS! en ey ose

NAME: 177Lu-DOTA-EB-TATE

(EBTATE)
INDICATION: Neuroendocrine Neoplasms (NEN)
PROOF OF CONCEPT: Extensive preclinical and two
Phase | studies (50 patients) performed by NIH and
Peking Union Medical College Hospital (China)
PRINCIPAL COLLABORATORS: NIH & Memorial
Sloan Kettering Medical Center

OWNERSHIP: MTTI awarded world-wide-exclusive
rights by NIH.

callin stine/M

NAME: 1311 SapC-DOPS

INDICATION: Glioblastoma (Brain Cancer)

STAGE OF DEVELOPMENT: Preclinical. Seeking
partner.

PRINCIPAL COLLABORATOR: University of Cincinnati
IP: Pending

FUNDING: Obtained funding from NCI.

OWNERSHIP: MTTI is establishing an option

NAME: LeishCure

INDICATION: Cutaneous Leishmaniasis (CL)

STAGE OF DEVELOPMENT: Preclinical. Seeking
partner.

PRINCIPAL COLLABORATOR: University of Notre
Dame (UND)

IP: Multiple approved and pending patents on Zn-DPA:
US7,179,616; 8,389,223 and 9,211,349.

FUNDING: Obtained funding from NIAID.
OWNERSHIP: MTTIVUND

btte Aww miarcet om

IP: MTTI/NHRI US Patent 9,388,193B2 July 12, 2016
OWNERSHIP: MTTI/NHRI sublicensed ZAPS
technology to Taivex Pharmaceutical

nlarget. com/mms/pdfs/pipeline/Asset'e20 %

NAME: AMISCAN

The company has completed a Phase II study funded
by NHLBI to assess the ability of 99mTcglucarate to
detect cardiac ischemia in chest pain patients.

bitp Ave miarget eom/mmo/pdisipipeling/AMISCANIa
p20 18March pdt

NAME: TDURA

CLASS: Imaging Agent

INDICATIONSancer, injury due to drug toxicity,
atherosclerotic plaque and acute myocardial infarction
STAGE OF DEVELOPMENT: Ready for Phase 0/1
development in 2018. Seeking partner.

PRINCIPAL COLLABORATOR: University of Antwerp
MICA (Molecular Imaging Center Antwerp)

IP: US 7,877,783 B2, US 8,778,303B2, Chinese patent
CN102014970B, European approved 2017. These
patents are secure through 2029 in US, EU and China.
MTTI obtained an exclusive license from the

Medical College of Wisconsin.

FUNDING: Obtained ~$1 million non-dilutive grants
from NIH & EU.

OWNERSHIP: MTTI

tte Avan miarget oe

NAME: CypH

CLASS: Diagnostic Spray for Guided Surgery
INDICATION: Ovarian cancer surgery

STAGE OF DEVELOPMENT: Preclinical. Seeking
partner.

PRINCIPAL COLLABORATOR: Cornell Medical
College

IP: Pending patents owned by Methodist Hospital,
Houston, Texas

FUNDING: Secured funding from NCI
OWNERSHIP: MTTI is establishing an option
agreement with Methodist Hospital

Page 4 of 7

REL0000023675.0001

Further issues Related to the License

Ownership. When the public grants a monopoly on a taxpayer-funded invention, there should
be much greater transparency in the process. This transparency should extend to the ownership
of the entity seeking an exclusive license. In the United States, publicly-traded companies are
required to disclose major shareholders. We ask that the NIH obtain and provide to the public
information about who owns any privately-held companies seeking exclusive licenses from the
NIH. Related to this issue is the question of foreign ownership. A company can be incorporated
in the United States, but have foreign ownership. In our experience, the NIH does not identify or
at least does not disclose the ownership of privately-held companies seeking exclusive licenses
on taxpayer-funded inventions.

Government role in funding future development. If there is any expectation that the NIH will
provide future funding to further develop the technology, that information should be disclosed to
the public, and taken into account in negotiating the term of exclusivity in the license. If the U.S.
government will be funding any human subject clinical trials relevant to the new license, the
period of exclusivity should be reduced to reflect the need for a smaller incentive.

Terms of the proposed license. In recent years, the NIH has refused to describe the term of
exclusivity or the royalty rate for a proposed license. Both the royalty rate and the number of
years of exclusivity are quite important in evaluating if the NIH is protecting the public interest.
We note that in 2018, the NIH reported a mere $118 million in royalty payments for all licenses
(httes /www. ott nih gov/reporisstais/ott-statistics). For the license at hand, we requested the
expected royalty rate and statistical data on past licenses for cancer diagnostics and cancer
therapeutics, and the NIH declined to provide such information (which we assume the NIH has
readily available. The NIH also declined to specifically confirm the expected term of exclusivity,
although there was a strong suggestion that the NIH always grants life-of-patent licenses,
despite the statutory requirement to limit the scope of each individual license to that which is
reasonably necessary to induce investments.

Expected Development Costs. The NIH needs to have an estimate of the expected costs of
bringing a technology to practical application, in order to assist in the evaluation of the number
of years of exclusivity and other elements of the scope of rights granted.

You have been very helpful in answering several questions about the technology to be licensed.
The NIH needs to be more open about the terms of the license, beyond the field of use, and the

rationale for the scope of exclusive rights.

In addition to any of the points discussed above, we ask that going forward the NIH provide the
following information to the public so that comments on the license can be better informed:

Page 5 of 7

REL0000023675.0001

(1) The specific countries where exclusive rights will be licensed;

(2) An estimate of the public expenditures on research and development associated
with the inventions to be licensed;

(3) The proposed term of exclusivity for the license;

(4) The proposed royalty;

(5) The expected cost of bringing the invention to practical application;

(6) The measures proposed to ensure the inventions will be made available to the
public on reasonable terms;

(7) The measures proposed to ensure access to the inventions in developing
countries;

(8) The anticipated non-patent exclusive rights or other incentives associated with
the development of the inventions, such as the Orphan Drug Act exclusivity or
the Priority Review Voucher; and

(9) The economic analysis, if any, that was used to determine that exclusive rights
were necessary, and if so, how the scope of rights, including the term of the
exclusive rights, was limited to that which is a reasonably necessary incentive in
order to bring the invention to practical application.

Proposals for Additional Safeguards

. Price discrimination. Any drug or other medical technology using the patented
invention should be available in the United States at a price that does not exceed the
median price in the seven largest economies by GDP that have at least 50 percent of the
GNI per capita as the United States, using the World Bank Atlas method. This is a
modest safeguard.

Low and middle income countries. The exclusive license should not extend to
countries with a per capita income less than 30 percent of the United States, in order to
ensure that the patents do not lead to restricted and unequal access in developing
countries. If the NIH rejects this suggestion, it needs to provide something that will give
effect to the policy objective in the “United States Public Health Service Technology
Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy,” which states the
following: “PHS seeks to promote commercial development of inventions in a way that
provides broad accessibility for developing countries.”

. Global registration and affordability. The license should require Molecular Targeting
Technologies, Inc, to disclose the steps it will take to enable the timely registration and
availability of the drug or other medical technology at an affordable price in the United
States and in every country with a demonstrated need, according to the Centers for
Disease Control and Prevention (CDC) and/or the World Health Organization (WHO),
either by supplying a country directly at an affordable, publicly disclosed price and with
sufficient quantities, or by providing technology transfer and rights to all intellectual
property necessary for third parties to do so.

Page 6 of 7

REL0000023675.0001

4, Medicines Patent Pool. The NIH should retain a right to grant the WHO, the Medicines
Patent Pool or other governments the rights to use the patent rights to procure the drug
or other medical technology from competitive suppliers, including technology transfer, in
developing countries, upon a finding by HHS or the WHO that people in these markets
do not have sufficient access to the drug or other medical technology.

5. Years of exclusivity. We propose the license reduce the years of exclusivity when
revenues are large. The NIH has many options, including by providing an option for
non-exclusive licensing, such as was done in the ddl case. We propose that the
exclusivity of the license be reduced when the global cumulative sales from products or
services using the inventions exceed certain benchmarks. For example, the period of
exclusivity in the license could be reduced by one year for every $500 million in global
cumulative revenue after the first one billion in global sales. This request is consistent
with the statutory requirements of 35 U.S.C. § 209, which requires that “the proposed
scope of exclusivity is not greater than reasonably necessary to provide the incentive for
bringing the invention to practical application.”

6. Transparency of R&D outlays. The licensee should be required to file an annual report
to the NIH, available to the public, on the research and development (R&D) costs
associated with the development of any product or service that uses the inventions,
including reporting separately and individually the outlays on each clinical trial. We will
note that this is not a request to see a company business plan or license application. We
are asking that going forward the company be required to report on actual R&D outlays
to develop the subject inventions. Reporting on actual R&D outlays is important for
determining if the NIH is meeting the requirements of 35 U.S.C. § 209, that “the
proposed scope of exclusivity is not greater than reasonably necessary to provide the
incentive for bringing the invention to practical application.” Specifically, having data on
actual R&D outlays on each clinical trial used to obtain FDA approval provides evidence
that is highly relevant to estimating the risk adjusted costs of bringing NIH licensed
inventions to practical application.

Sincerely,

Knowledge Ecology International
Union for Affordable Cancer Treatment

Page 7 of 7

REL0000023675.0001

Office of Technology Transfer and Development
31 Center Drive Room 4A29, MSC2479

National Heart, Lung, Bethesda, MD 20892-2479

: F Michael Shmilovich, Esq, CLP
and

lood uystitute shmilovm@mail.nih.gov

August 25, 2019
James Packard Love
Luis Gil Abinader

Dr. Manon Anne Ress

INRE: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that overexpress Integrin avB3
84 FR 39001 (to Molecular Targeting Technologies, Inc. (MTTI)).

Dear Messrs. Love, Abinader and Dr. Ress:

Sincerely,

Michael A. Shmilovich, Esq., CLP

REL0000023675.0002

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]

Sent: 8/23/2019 10:16:56 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Pazman, Cecilia
(NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]; Berkley, Dale (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]; Goldstein, Bruce (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cb67e8fe5aa2452a8a7f200e5fb4335b-goldsteb]

Subject: Fwd: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that Overexpress Integrin
avB3, 84 FR 39001

Attachments: KEI Comments, NIH License to MTTI, Described in 84 FR 39001 .pdf

ed. It appears to only be comments that includes their standard boiler

"

From: "James Love" <james.love@keionline.o

Date: Friday, August 23, 2019 at 16:16:14

To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>

Ce: "Kathryn Ardizzone" <kathryn.ardizzone@keionline.org>, "Manon Ress"
<MANON.RESS@cancerunion.org>, "Luis Gil Abinader" <luis.gil.abinader@keionline.org>, "Claire Cassedy"
<claire.cassedy@kecionline.org>

Subject: Re: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that Overexpress
Integrin avB3, 84 FR 39001

Michael Shmilovich, Esq.

Senior Licensing and Patent Manager
National Heart, Lung, and Blood Institute
31 Center Drive

Bethesda, MD 20892

Comments from KEI and UACT are attached.

James Love. Knowledge Ecology International
U.S. Mobile +1.202.361.3040
USS. office phone +1.202.332.2670

http://www.keionline.org
twitter.com/jamie love

REL0000023677

KNOWLEDGE ECOLOGY
INTERNATIONAL

1621 Connecticut Avenue NW
Suite 500
Washington, DC 20009
www.keionline.org
August 23, 2019

Michael Shmilovich, Esq.

Senior Licensing and Patent Manager
National Heart, Lung, and Blood Institute
31 Center Drive

Bethesda, MD 20892

Re: Prospective Grant of Exclusive Patent License: Radiotherapeutic against Cancers that
Overexpress Integrin avB3, 84 FR 39001

Dear Mr. Shmilovich:

Knowledge Ecology International (KEI) and the Union for Affordable Cancer Treatment (UACT)
are writing to comment on the prospective grant of an exclusive patent license in “a
radiotherapeutic against cancers that overexpress integrin av63” to Molecular Targeting
Technologies, Inc. (MTTI), as referenced in the notice located at 84 FR 39001.

The 84 FR 39001 notice is the third time since 2018 that the NIH has published a notice
concerning an exclusive license with MTTI in the same patent family, but it adds a new field of
use.

The previous exclusive license and a proposed amendment between the NIH and MTTI for
Lutetium-177 technologies were:

e The prospective license noticed on July 27, 2018 (83 FR 35663), which described a
prospective exclusive license to MTTI in “Radiotherapeutics Against
Somatostatin-Receptor Expressing Neuroendocrine Tumors,” and

e A prospective amendment to the 2018 license noticed on June 17, 2019 (84 FR 28063),
for “Lutetium-177 Radiotherapeutics Against Somatostatin-Receptor Expressing
Neuroendocrine Tumors.”

REL0000023677.0001

KEI filed comments in both of these cases, and copies of those comments are available here:
https www. keionline oramih-licenses. The July 2, 2019 comments were filed jointly with the
Union for Affordable Cancer Treatment (UACT), and three individuals in their personal capacity,
James Love, Manon Ress and Luis Gil Abinader. We ask that the comments regarding the
earlier licenses be included in the record for this license, by reference, and also that the
suggestions for safeguards in that license that were set forth in the July 2, 2019 comments be
considered here for the new license (see below).

The Subject Invention and Patent Estate
Thank you for answering several of our questions about this new license.

Per your answers, it is our understanding that the original licensing opportunity was published in
2015 and updated in 2016, as “early stage.”

Long Acting Therapeutic Conjugates with Evans Blue

The licensing opportunity notice describes the patent estate as “a platform technology that
pertains to the advantages of conjugating therapeutics to Evans Blue thus providing long lasting
pharmacokinetic profiles by complexing with albumin.”

You have described this as a new license that expands the field of use for the same patent
estate identified in 84 FR 28063. In your August 23, 2019 email, you compare the new license
to the previous MTTI/lu-177 license and its proposed amendment as follows:

The fields of use and cancer targets are different. The targeting moiety in the previous
field of use licensed to the company is tetraazacyclododecanetetraacetic acid-octreotide
(TATE) which binds to somatostatin receptor present on neuroendocrine tumors. The
targeting moiety in the instant contemplated field is the RGD peptide
arginylglycylaspartic acid which binds to integrin avB3 that is overexpressed on a variety
of different cancers; however, the present field of use would be limited to only
glioblastoma multiforme and small cell lung cancers.

In the event that the NIH decides to grant this exclusive license, we ask that safeguards be

placed on the license to protect the public from (a) unreasonable pricing, (b) excessive terms of
exclusivity, (c) to address access in developing countries, and (d) to enhance transparency. Our
specific suggestions for safeguards are listed below, following further discussion of the licensee.

MTTI

Molecular Targeting Technologies, Inc. (MTTI) appears to be a small privately held firm with few
employees of its own, that has considerable success in obtaining NIH grants, either directly or

Page 2 of 7

REL0000023677.0001

indirectly through non-profit institutions. According to the NIH REPORTER database, MTTI has
received funding from the FDA and/or the NIH every year since 1998.

Table 1: NIH RePORTER figures for MTTI grant funding by fiscal year

Fiscal Year Projects Total Funding
1995 1 $98,500
1998 1 $100,000
1999 1 $134,600
2000 1 $100,000
2001 1 $372,700
2002 2 $727,300
2003 2 $513,688
2004 1 $335,239
2005 1 $418,825
2006 2 $891,387
2007 3 $1,853,974
2008 3 $1,732,733
2009 6 $1,891,013
2010 2 $572,812
2011 1 $414,018
2012 3 $1,457,619
2013 2 $1,078,417
2014 2 $1,055,660
2015 1 $224,819
2017 2 $514,163
2018 2 $279,610
2019 2 $608,921
Total 42 $15,375,998

MTTI has also benefited from NIH grants to other institutions. For example, MTTI has received
NIH funds through grants to Thomas Jefferson University and other research institutions.

Of the eight projects, seven report funding from the NIH. The only project without NIH funding
reports funding from the government of Taiwan.

NAME: Rabies mAb NAME: ZAPS SN-38
IP: MTTI licensed from the Thomas Jefferson University | INDICATION: Cancer
North China Pharmaceutical Company (NCPC) is STAGE OF DEVELOPMENT: Phase | clinical planned

initiating the phase III clinical trial in China in 2018. by Taivex Pharmaceutical in 2019.
PARTNER : MTTI sublicensed the product to North PARTNER: National Health Research Institutes (NHRI,
China Pharmaceutical Company in exchange for future | Taiwan) for preclinical studies.

Page 3 of 7

REL0000023677.0001

royalty stream. NCPC is responsible for all clinical
development costs.

IP: MTTI licensed from the Thomas Jefferson University
FUNDING: $425,000 from USDA (2006); $918,000 from
NIH (2007).

OWNERSHIP: MTTI shares co-exclusive rights in China
with Johnson & Johnson (previously Crucell).

f

CGR OTS men ey ose

FAR ASAY

NAME: 177Lu-DOTA-EB-TATE

(EBTATE)
INDICATION: Neuroendocrine Neoplasms (NEN)
PROOF OF CONCEPT: Extensive preclinical and two
Phase | studies (50 patients) performed by NIH and
Peking Union Medical College Hospital (China)
PRINCIPAL COLLABORATORS: NIH & Memorial
Sloan Kettering Medical Center

OWNERSHIP: MTTI awarded world-wide-exclusive
rights by NIH.

callin stine/M

NAME: 1311 SapC-DOPS

INDICATION: Glioblastoma (Brain Cancer)

STAGE OF DEVELOPMENT: Preclinical. Seeking
partner.

PRINCIPAL COLLABORATOR: University of Cincinnati
IP: Pending

FUNDING: Obtained funding from NCI.

OWNERSHIP: MTTI is establishing an option

NAME: LeishCure

INDICATION: Cutaneous Leishmaniasis (CL)

STAGE OF DEVELOPMENT: Preclinical. Seeking
partner.

PRINCIPAL COLLABORATOR: University of Notre
Dame (UND)

IP: Multiple approved and pending patents on Zn-DPA:
US7,179,616; 8,389,223 and 9,211,349.

FUNDING: Obtained funding from NIAID.
OWNERSHIP: MTTIVUND

bitte Aas miaroet oe

IP: MTTI/NHRI US Patent 9,388,193B2 July 12, 2016
OWNERSHIP: MTTI/NHRI sublicensed ZAPS
technology to Taivex Pharmaceutical

hitec/Awww miargel com/mmS/pdts/mipeline/Assethc20 2%

3 Roe LIOR

NAME: AMISCAN

The company has completed a Phase II study funded
by NHLBI to assess the ability of 99mTcglucarate to
detect cardiac ischemia in chest pain patients.

http Ave miarget eom/mmo/pdisipipeling/AMISCANIa
n2018March pdt

NAME: TDURA

CLASS: Imaging Agent

INDICATIONSancer, injury due to drug toxicity,
atherosclerotic plaque and acute myocardial infarction
STAGE OF DEVELOPMENT: Ready for Phase 0/1
development in 2018. Seeking partner.

PRINCIPAL COLLABORATOR: University of Antwerp
MICA (Molecular Imaging Center Antwerp)

IP: US 7,877,783 B2, US 8,778,303B2, Chinese patent
CN102014970B, European approved 2017. These
patents are secure through 2029 in US, EU and China.
MTTI obtained an exclusive license from the

Medical College of Wisconsin.

FUNDING: Obtained ~$1 million non-dilutive grants
from NIH & EU.

OWNERSHIP: MTTI

AI88 9, A Parcs

NAME: CypH

CLASS: Diagnostic Spray for Guided Surgery
INDICATION: Ovarian cancer surgery

STAGE OF DEVELOPMENT: Preclinical. Seeking
partner.

PRINCIPAL COLLABORATOR: Cornell Medical
College

IP: Pending patents owned by Methodist Hospital,
Houston, Texas

FUNDING: Secured funding from NCI
OWNERSHIP: MTTI is establishing an option
agreement with Methodist Hospital

bite /Avwaw miarget com/muinS/ndis/s)

Page 4 of 7

REL0000023677.0001

Further issues Related to the License

Ownership. When the public grants a monopoly on a taxpayer-funded invention, there should
be much greater transparency in the process. This transparency should extend to the ownership
of the entity seeking an exclusive license. In the United States, publicly-traded companies are
required to disclose major shareholders. We ask that the NIH obtain and provide to the public
information about who owns any privately-held companies seeking exclusive licenses from the
NIH. Related to this issue is the question of foreign ownership. A company can be incorporated
in the United States, but have foreign ownership. In our experience, the NIH does not identify or
at least does not disclose the ownership of privately-held companies seeking exclusive licenses
on taxpayer-funded inventions.

Government role in funding future development. If there is any expectation that the NIH will
provide future funding to further develop the technology, that information should be disclosed to
the public, and taken into account in negotiating the term of exclusivity in the license. If the U.S.
government will be funding any human subject clinical trials relevant to the new license, the
period of exclusivity should be reduced to reflect the need for a smaller incentive.

Terms of the proposed license. In recent years, the NIH has refused to describe the term of
exclusivity or the royalty rate for a proposed license. Both the royalty rate and the number of
years of exclusivity are quite important in evaluating if the NIH is protecting the public interest.
We note that in 2018, the NIH reported a mere $118 million in royalty payments for all licenses
(httes /www_ ott nih gov/reportsstais/ott-statistics). For the license at hand, we requested the
expected royalty rate and statistical data on past licenses for cancer diagnostics and cancer
therapeutics, and the NIH declined to provide such information (which we assume the NIH has
readily available. The NIH also declined to specifically confirm the expected term of exclusivity,
although there was a strong suggestion that the NIH always grants life-of-patent licenses,
despite the statutory requirement to limit the scope of each individual license to that which is
reasonably necessary to induce investments.

Expected Development Costs. The NIH needs to have an estimate of the expected costs of
bringing a technology to practical application, in order to assist in the evaluation of the number
of years of exclusivity and other elements of the scope of rights granted.

You have been very helpful in answering several questions about the technology to be licensed.
The NIH needs to be more open about the terms of the license, beyond the field of use, and the

rationale for the scope of exclusive rights.

In addition to any of the points discussed above, we ask that going forward the NIH provide the
following information to the public so that comments on the license can be better informed:

Page 5 of 7

REL0000023677.0001

(1) The specific countries where exclusive rights will be licensed;

(2) An estimate of the public expenditures on research and development associated
with the inventions to be licensed;

(3) The proposed term of exclusivity for the license;

(4) The proposed royalty;

(5) The expected cost of bringing the invention to practical application;

(6) The measures proposed to ensure the inventions will be made available to the
public on reasonable terms;

(7) The measures proposed to ensure access to the inventions in developing
countries;

(8) The anticipated non-patent exclusive rights or other incentives associated with
the development of the inventions, such as the Orphan Drug Act exclusivity or
the Priority Review Voucher; and

(9) The economic analysis, if any, that was used to determine that exclusive rights
were necessary, and if so, how the scope of rights, including the term of the
exclusive rights, was limited to that which is a reasonably necessary incentive in
order to bring the invention to practical application.

Proposals for Additional Safeguards

. Price discrimination. Any drug or other medical technology using the patented
invention should be available in the United States at a price that does not exceed the
median price in the seven largest economies by GDP that have at least 50 percent of the
GNI per capita as the United States, using the World Bank Atlas method. This is a
modest safeguard.

Low and middle income countries. The exclusive license should not extend to
countries with a per capita income less than 30 percent of the United States, in order to
ensure that the patents do not lead to restricted and unequal access in developing
countries. If the NIH rejects this suggestion, it needs to provide something that will give
effect to the policy objective in the “United States Public Health Service Technology
Transfer Policy Manual, Chapter No. 300, PHS Licensing Policy,” which states the
following: “PHS seeks to promote commercial development of inventions in a way that
provides broad accessibility for developing countries.”

. Global registration and affordability. The license should require Molecular Targeting
Technologies, Inc, to disclose the steps it will take to enable the timely registration and
availability of the drug or other medical technology at an affordable price in the United
States and in every country with a demonstrated need, according to the Centers for
Disease Control and Prevention (CDC) and/or the World Health Organization (WHO),
either by supplying a country directly at an affordable, publicly disclosed price and with
sufficient quantities, or by providing technology transfer and rights to all intellectual
property necessary for third parties to do so.

Page 6 of 7

REL0000023677.0001

4, Medicines Patent Pool. The NIH should retain a right to grant the WHO, the Medicines
Patent Pool or other governments the rights to use the patent rights to procure the drug
or other medical technology from competitive suppliers, including technology transfer, in
developing countries, upon a finding by HHS or the WHO that people in these markets
do not have sufficient access to the drug or other medical technology.

5. Years of exclusivity. We propose the license reduce the years of exclusivity when
revenues are large. The NIH has many options, including by providing an option for
non-exclusive licensing, such as was done in the ddl case. We propose that the
exclusivity of the license be reduced when the global cumulative sales from products or
services using the inventions exceed certain benchmarks. For example, the period of
exclusivity in the license could be reduced by one year for every $500 million in global
cumulative revenue after the first one billion in global sales. This request is consistent
with the statutory requirements of 35 U.S.C. § 209, which requires that “the proposed
scope of exclusivity is not greater than reasonably necessary to provide the incentive for
bringing the invention to practical application.”

6. Transparency of R&D outlays. The licensee should be required to file an annual report
to the NIH, available to the public, on the research and development (R&D) costs
associated with the development of any product or service that uses the inventions,
including reporting separately and individually the outlays on each clinical trial. We will
note that this is not a request to see a company business plan or license application. We
are asking that going forward the company be required to report on actual R&D outlays
to develop the subject inventions. Reporting on actual R&D outlays is important for
determining if the NIH is meeting the requirements of 35 U.S.C. § 209, that “the
proposed scope of exclusivity is not greater than reasonably necessary to provide the
incentive for bringing the invention to practical application.” Specifically, having data on
actual R&D outlays on each clinical trial used to obtain FDA approval provides evidence
that is highly relevant to estimating the risk adjusted costs of bringing NIH licensed
inventions to practical application.

Sincerely,

Knowledge Ecology International
Union for Affordable Cancer Treatment

Page 7 of 7

REL0000023677.0001

From: Rodriguez, Richard (NIH/NCI) [E] [/O=NIH/OU=NIHEXCHANGE/CN=OD/CN=RODRIQUR]

Sent: 3/14/2017 6:37:01 PM
To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]
Subject: RE: Anyone have objection from KEI in 2017

No I haven't. I thought they had just stopped when I hadn't heard any TTMs mentioning them.

----- Original Message-----

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, March 14, 2017 1:36 PM

To: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>
Subject: Re: Anyone have objection from KEI in 2017

I asked your folks here at AUTM and I hear back from Dave and Jim. No one seems to have gotten the
exclusive license objections from KEI in 2017 that they were getting last year. Have you heard anything
different?

Sent from my iPhone

> On Mar 14, 2017, at 12:17 PM, Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov> wrote:

>

> Hi Mark,

>

> I'm not sure what you are specifically asking for here but you might get a more complete response if

you also send this to the ELCG email group. I'm not sure everyone doing licensing is on the NIH Long
list.

>

> Richard

>

> ooeeoe Original Message-----

> From: Rohrbaugh, Mark (NIH/OD) [E]

> Sent: Monday, March 13, 2017 5:00 PM

> To: NIH TDC Long <niaaatdcl-1@mail.nih.gov>
> Subject: Anyone have objection from KEI in 2017
>

> From FR notice of intent to grant?

>

> Thx

> Mark

>

> Sent from my iPhone

REL0000023678

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]

Sent: 8/23/2019 1:07:02 PM

To: Berkley, Dale (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]; Rohrbaugh, Mark (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: RE: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice

Dale — can’t explain in a sentence. |’ll try to come up with a response and send your way to look through.

From: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>

Sent: Friday, August 23, 2019 9:00 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @oad.nih.gov>; Shmilovich, Michael (NIH/NHLBI) [E]
<michael.shmilovich@nih.gov>

Subject: FW: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001
Notice

response.

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528 (Fax)

This message 1s intended for the exclusive use of the reciptent(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and it should not be disseminated,
distributed, or copied to persons not authorized to recerve such information.

From: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@ nih.gov>

Sent: Friday, August 23, 2019 8:27 AM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>

Subject: Fwd: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001
Notice

Date: Friday, August 23, 2019 at 06:35:50

To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Shmilovich, Michael
(NIH/NHLBIP [E]" <michael.shmilovich@nih.gov>

Ce: "James Love" <james.love@kcionline.org>

Subject: Additional questions about the technology in the proposed exclusive license described in the 84 FR
39001 Notice

Dear Mr. Shmilovich:

In light of the upcoming deadline to submit comments, please respond to the following questions as
soon as practicable.

REL0000023680

1. What is the relationship between the subject technology and the technology covered by the recent
past licenses to MTTI (described in 83 FR 35663 and 84 FR 28063)?

2. KEI understands that the 84 FR 28063 license amended the license that resulted from 83 FR
35663. Please confirm that the license in the instant notice would be an additional, separate license
and not an amendment.

3. What is the relationship between the intellectual property in the present license notice and the
previous license/amendment to MTTI?

4. What is the relationship between the field of use of the license and the previous
license/amendment to MTTI. For example, the previous licenses pertained to a

radiotherapeutic against neuroendocrine tumors that express somatostatin receptor. Radionuclide
therapies directed against tumors that express somatostatin receptors (SSTRs) have proven effective
for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors.” The current notice
pertains to radiotherapeutic against cancers that overexpress integrin avB3, including small cell lung
cancers. Neuroendocrine tumors may include small cell lung cancers. Are the small cell lung
cancers that would be targeted by the subject technology neuroendocrine tumors? Does the
new field of use expand or does it modify the previous fields of use to MTTI?

5. Has the NIH, NHLBI, or any institute of the NIH ever published, online, a licensing opportunity
notice for the subject invention? If so, where is it located?

6. What are the clinical trial numbers that pertain to the instant technology? How much did the trials
cost?

7. Has the NIH sought the advice of the Attorney General under 40 U.S.C. § 559? If not, has it
considered the potential anti-competitive effect of the license?

8. What is the NIH's rationale for giving additional IP rights to a company that is already obligated to
commercialize the technology under the previous licensing agreement?

9. How and why has the NIH determined that the prospective license would comply with Section 209
of the Bayh Dole Act?

Thank you,

Kathryn Ardizzone, Esq.

Counsel

Knowledge Ecology International

1621 Connecticut Avenue NW, Suite 500
Washington, DC 20009
kathryn.ardizzone(@keionline.org

(202) 332-2670

REL0000023680

From:
Sent:
To:
cc:

Subject:

Hi Mark,

Baden, Elizabeth (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=BADENEM]

3/14/2017 4:13:02 PM

Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=O0D/cn=ROHRBAUM]
Baden, Elizabeth (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=Badenem]

RE: edits to the Drug Pricing BRAIN brief

Thanks se much for the quick feedback. I've incorporated the relevant info in the BRAIN record. | have one more

question.

Best,
Elizabeth

From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Monday, March 13, 2017 6:46 PM
To: Baden, Elizabeth (NIH/OD) [E] <badenem@od.nih.gov>
Subject: Re: edits to the Drug Pricing BRAIN brief

The quick feedback | have gotten is that KEI has not filed objections in at least 2 notices this CY

Sent from my iPhone

Hi Mark,

Jen for the information below. |

“and also rearranged the key points!
L

stasevsenvnertesstavnenssestsDWasuevacevetsenenenenererdekevueaces

if you have a chance, please look at the attached version. My changes are tracked. If this look ok to you,
then | can make the changes in BRAIN.

Thanks!
Elizabeth

From: Rohrbaugh, Mark (NIH/OD) [E]
Sent: Monday, March 13, 2017 6:02 AM

To: Volkov, Marina (NIH/OD) [E] <r
Ce: Baden, Elizabeth (NIH/OD) [E] <badenem @

od nih.gzov>

Subject: Re: edits to the Drug Pricing BRAIN brief

REL0000023683

KEI said last year it would appeal to the new HHS Sec'y on Xtandi, and they continue to object to
proposed exclusive licensing of specific technologies when public notice is made in FR. Pricing and
exclusivity is a current public issue with the Army's proposed Zika vaccine and NIAID is likely to get the
same heat when they get to a point of licensing theirs.

With drug pricing issues continuing to fester and comments from the administration about addressing
the high price of drugs, we are likely to see more pressure at least from advocacy groups on this issue.

Sent from my iPhone

On Mar 12, 2017, at 8:49 PM, Volkov, Marina (NIH/OD) [E] <mvelkev@od.nih.gov> wrote:

Hi Mark,

Dr. Tabak has made the following comment on the Drug Pricing BRAIN brief:

Any chance you can make these changes tomorrow (Monday)? Dr. Collins will be
starting his study of the briefs on Monday, so we need to wrap everything up by then.

Thanks,

Marina

<Drug Pricing v2.docx>

REL0000023683

From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]

Sent: 8/23/2019 2:39:30 PM

To: Shmilovich, Michael (NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7dfe19bfd1d443ceb700b9f22d159a90-shmilovm]; Rohrbaugh, Mark
(NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: RE: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001 Notice

See my proposed changes in red below.

Dale D. Berkley, Ph.D., J.D.

Office of the General Counsel, PHD, NIH Branch

Bldg. 31, Rm. 47

Bethesda, MD 20892

301-496-6043

301-402-2528(Fax)

‘This message is intended for the exclusive use of the recipsent(s) named above. It may contain information that is PROTECTED or PRIVILEGED, and st should not be disseminated,
distributed, or copied to persons not authorized to recetve such information.

From: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>

Sent: Friday, August 23, 2019 9:31 AM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>
Subject: RE: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001
Notice

Dale —please comment. My responses are in blue

From: "kathryn ardizzone" <kathryn.ardizzone@keionline.org>

Date: Friday, August 23, 2019 at 06:35:50

To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Shmilovich, Michael

Ce: "James Love" <james.love@keionline.org>

Subject: Additional questions about the technology in the proposed exclusive license described in the 84 FR
39001 Notice

Dear Mr. Shmilovich:

In light of the upcoming deadline to submit comments, please respond to the following questions as
soon as practicable.

1. What is the relationship between the subject technology and the technology covered by the recent
past licenses to MTTI (described in 83 FR 35663 and 84 FR 28063)?

2. KEI understands that the 84 FR 28063 license amended the license that resulted from 83 FR
35663. Please confirm that the license in the instant notice would be an additional, separate license
and not an amendment.

REL0000023684

3. What is the relationship between the intellectual property in the present license notice and the
previous license/amendment to MTTI?

4. What is the relationship between the field of use of the license and the previous
license/amendment to MTTI. For example, the previous licenses pertained to a

radiotherapeutic against neuroendocrine tumors that express somatostatin receptor. Radionuclide
therapies directed against tumors that express somatostatin receptors (SSTRs) have proven effective
for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors." The current notice
pertains to radiotherapeutic against cancers that overexpress integrin avB3, including small cell lung
cancers. Neuroendocrine tumors may include small cell lung cancers. Are the small cell lung
cancers that would be targeted by the subject technology neuroendocrine tumors? Does the
new field of use expand or does it modify the previous fields of use to MTTI?

5. Has the NIH, NHLBI, or any institute of the NIH ever published, online, a licensing opportunity
notice for the subject invention? If so, where is it located?
https: Sao ea fateniartee aac rep epee

November 16, 204 7}
bttps//www.ott.nih govtechnology/e-143-20 15

6. What are the clinical trial numbers that pertain to the instant technology? How much did the trials

7. Has the NIH sought the advice of the Attorney General under 40 U.S.C. § 559? If not, has it
considered the potential anti-competitive effect of the license?

rai ag ofan imme cnet toch ai hae cate cmd ast cinema ced an atm Pea alata nena bee along ah dacesbaeh detec ieee tanec ata tate neo amet atmentLeaacidaduiateter asec

8. What is the NIH's rationale for giving additional IP rights to a company that is already obligated to
commercialize the technology under the previous licensing agreement?

Mosca a'cia eac ia ean em lence ov aba nn cdi eco shes bach usc ace nee tat ease onetime Geena dees em ecanccinced amanda ean ee cclomaanimint nimi imieaeibinmemiacesminaimrataimimine

9. How and why has the NIH determined that the prospective license would comply with Section 209
of the Bayh Dole Act?

REL0000023684

Thank you,

Kathryn Ardizzone, Esq.

Counsel

Knowledge Ecology International

1621 Connecticut Avenue NW, Suite 500
Washington, DC 20009

kathryn. ardizzone@

S
<
a.
cS)
Pe
=
o
°
en]

(202) 332-2670

REL0000023684

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]

Sent: 8/23/2019 3:11:19 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Berkley, Dale (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5ee461c29f5045a49fOadf82caaa2f31-berkleyd]

Subject: RE: Other response to KEI

Mark- lets discuss when you return. As of this morning I received not less than 4 emails from Kathryn
and James Love with questions, many of which were technical and straight forward that I felt comfortable
answering. I'1]1 forward those to you.

w---- Original Message-----

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Friday, August 23, 2019 11:08 AM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>; Shmilovich, Michael (NIH/NHLBI) [E]
<michael.shmi lovich@nih. gov>

Subject: Other response to KEI

where are we with the other response I was going to send. If we agree on language I can send it this
morning.
b5 iNo response needed now

Sent from my iPhone

RELO000023686

From: Hammersia, Ann (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=87FB28AA23744COB855EF0683AC2E8B4-HAMMERSLAA]
Sent: 3/14/2018 7:53:27 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
Subject: FW: Request for Investigation Re Failure to Disclose Federal Funding in Patent No. 7,964,580

Attachments: HHS-Azar-KEl-Patent-7964580-SOF-14March2018.pdf

Mark: | have not read through completely and as far as | know this has not be assigned to Dr. Collins.

Ann

From: Andrew Goldman [mailto:andrew.goldman@keionline.org]

Sent: Tuesday, March 13, 2018 1:05 PM

To: secretary@hhs.gov

Cc: Levinson, Dan R (OIG/IO) <dan.levinson@oig.hhs.gov>; Hammersla, Ann (NIH/OD) [E] <hammerslaa@mail.nih.gov>
Subject: Request for Investigation Re Failure to Disclose Federal Funding in Patent No. 7,964,580

Dear Secretary Azar:

Attached, please find a copy of a request that you initiate an investigation into the failure to disclose federal funding
leading to the development of Patent No. 7,964,580, held by Gilead. This patent is the first patent listed for Gilead's

sofosbuvir and its other sofusbuvir-based treatments for the hepatitis C virus.

As we describe in further detail in the letter, the failure to disclose is a violation of the law under the Bayh-Dole Act and
permits the government to receive title to the invention. If a violation is found, we urge you to seek this remedy.

We request a meeting to discuss this matter with you at your earliest convenience.

Sincerely,

Andrew S. Goldman

Counsel, Policy and Legal Affairs
Knowledge Ecology International
andrew. goldman

RELO000023687

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]

Sent: 8/23/2019 12:22:32 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Pazman, Cecilia (NIH/NHLBI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=bf35741501e247d887acd224eaf9d679-pazmance]

Subject: Fwd: Additional questions about the technology in the proposed exclusive license described in the 84 FR 39001
Notice

Date: Friday, August 23, 2019 at 06:35:50
To: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>, "Shmilovich, Michael

(NIH/NHLBJ) [E]" <michael.shmilovich@nih.gov>

Ce: "James Love" <james.love@kcionline.org>

Subject: Additional questions about the technology in the proposed exclusive license described in the 84 FR
39001 Notice

Dear Mr. Shmilovich:

In light of the upcoming deadline to submit comments, please respond to the following questions as
soon as practicable.

1. What is the relationship between the subject technology and the technology covered by the recent
past licenses to MTTI (described in 83 FR 35663 and 84 FR 28063)?

2. KEI understands that the 84 FR 28063 license amended the license that resulted from 83 FR
35663. Please confirm that the license in the instant notice would be an additional, separate license
and not an amendment.

3. What is the relationship between the intellectual property in the present license notice and the
previous license/amendment to MTTI?

4. What is the relationship between the field of use of the license and the previous
license/amendment to MTTI. For example, the previous licenses pertained to a

radiotherapeutic against neuroendocrine tumors that express somatostatin receptor. Radionuclide
therapies directed against tumors that express somatostatin receptors (SSTRs) have proven effective
for the treatment of advanced, low- to intermediate-grade neuroendocrine tumors.” The current notice
pertains to radiotherapeutic against cancers that overexpress integrin avB3, including small cell lung
cancers. Neuroendocrine tumors may include smail cell lung cancers. Are the small cell lung
cancers that would be targeted by the subject technology neuroendocrine tumors? Does the
new field of use expand or does it modify the previous fields of use to MTTI?

5. Has the NIH, NHLBI, or any institute of the NIH ever published, online, a licensing opportunity
notice for the subject invention? If so, where is it located?

6. What are the clinical trial numbers that pertain to the instant technology? How much did the trials
cost?

REL0000023689

7. Has the NIH sought the advice of the Attorney General under 40 U.S.C. § 559? If not, has it
considered the potential anti-competitive effect of the license?

8. What is the NIH’s rationale for giving additional IP rights to a company that is already obligated to
commercialize the technology under the previous licensing agreement?

9. How and why has the NIH determined that the prospective license would comply with Section 209
of the Bayh Dole Act?

Thank you,

Kathryn Ardizzone, Esq.

Counsel

Knowledge Ecology International

1621 Connecticut Avenue NW, Suite 500
Washington, DC 20009

kathryn.ardizzone@keionline.org
(202) 332-2670

REL0000023689

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]
Sent: 8/23/2019 3:20:04 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: FW: 84 FR 39001

.. These...

From: Shmilovich, Michael (NIH/NHLBI) [E]
Sent: Friday, August 23, 2019 9:45 AM

To: James Love <james.love@keionline.org>
Subject: RE: 84 FR 39001

| do not have information regarding their investors and that information is confidential.

From: James Love <james.love@keionline.org>

Sent: Friday, August 23, 2019 8:38 AM

To: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>
Subject: Re: 84 FR 39001

Thank you. So the three different licenses all involve Lu-177, but are different also, in ways the require the
separate licenses.

| noticed the lead researcher is from China, was is the founder of Molecular Targeting Technologies, Inc.
(MTTI), and that there have been trials in China. Do you know who the investors are in MTTI? For example, is
this a company with Chinese investors?

Jamie

On Fri, Aug 23, 2019 at 8:25 AM Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov> wrote:
Not related. Different tumor, different targeting molecule.

From: "James Love" <james.love@keionline.org>

Date: Thursday, August 22, 2019 at 16:27:42

To: "kathryn ardizzone" <kathryn.ardizzone@keionline.org>

Ce: "Shmilovich, Michael (NIH/NHLBI) [E]" <michael.shmilovich@nih.gov>
Subject: Re: 84 FR 39001

Dear Michael, is this trial related to the technology in the proposed license?

hitps://clinicaltrials.gov/ct2/show/record/NCT 03478358?term=eb-tate&rank=2

On Wed, Aug 21, 2019 at 5:15 PM James Love <james.love@keionline.org> wrote:

: In terms of the royalty data, if the technology is expected to be used for a therapeutic use, the statistical data
__ on licenses should be for licenses involving therapeutics for cancer.

REL0000023691

From: Shmilovich, Michael (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=7DFE19BFD1D443CEB700B9F22D159A90-SHMILOVM]

Sent: 8/23/2019 3:21:09 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

Subject: FW: 84 FR 39001

From: Shmilovich, Michael (NIH/NHLBI) [E]
Sent: Friday, August 23, 2019 9:44 AM

To: James Love <james.love@keionline.org>
Subject: RE: 84 FR 39001

| don’t have access to that information, you are free to contact the company if they are willing to divulge that

information.

From: James Love <james.love@keionline.org>
Sent: Friday, August 23, 2019 9:35 AM

To: Shmilovich, Michael (NIH/NHLBI) [E] <michael.shmilovich@nih.gov>

Subject: Re: 84 FR 39001

As far as we can tell, the NIH is funding every single one of MTTI's pipeline products. Is there an account of
how much money the NIH is providing for each of these projects? And more importantly for this license, how

much the NIH conducted or funded trials cost?

Jamie

NAME: Rabies mAb

IP: MTTI licensed from the Thomas Jefferson University

North China Pharmaceutical Company (NCPC) is initiating the phase III
clinical trial in China in 2018.

PARTNER : MTTI sublicensed the product to North China Pharmaceutical
Company in exchange for

future royalty stream. NCPC is responsible for all clinical development
costs.

IP: MTTI licensed from the Thomas Jefferson University

FUNDING: $425,000 from USDA (2006); $918,000 from NIH (2007).
OWNERSHIP: MTTI shares co-exclusive rights in China with Johnson &
Johnson (previously Crucell)
http://www.mtarget.com/mm5/pdfs/pipeline/Asset%20Rabies%20mAb.pdf

NAME: 177Lu-DOTA-EB-TATE (EBTATE)

INDICATION: Neuroendocrine Neoplasms (NEN)

PROOF OF CONCEPT: Extensive preclinical and two Phase | studies (50
patients) performed by

NIH and Peking Union Medical College Hospital (China).

PRINCIPAL COLLABORATORS: NIH & Memorial Sloan Kettering Medical
Center

NAME: ZAPS SN-38

INDICATION: Cancer

STAGE OF DEVELOPMENT: Phase | clinical planned by Taivex
Pharmaceutical in 2019.

PARTNER: National Health Research Institutes (NHRI, Taiwan) f
preclinical studies.

IP: MTTI/NHRI US Patent 9,388,193B2 July 12, 2016
OWNERSHIP: MTTI/NHRI sublicensed ZAPS technology to Taiv
Pharmaceutical
http://www.mtarget.com/mm5/pdfs/pipeline/Asset%20ZAPS%20-
%20SN%2038.pdf

NAME: AMISCAN

The company has completed a phase || study funded by NHLBI t
assess the ability of 99mTcglucarate to detect cardiac ischemia it
pain patients.

http:/Awww.mtarget.com/mm5/pdfs/pipeline/AMISCANjan2018Mal

NAME: TDURA

CLASS: Imaging Agent

INDICATION: cancer, injury due to drug toxicity, atherosclerotic ¢
and acute myocardial infarction

REL0000023692

OWNERSHIP: MTTI awarded world-wide-exclusive rights by NIH. STAGE OF DEVELOPMENT: Ready for Phase 0/1 development

htto://www.mtarget.com/mm5/pdfs/pipeline/MTTI%20Asset™20EBTATE.pdf | 2018. Seeking partner.
PRINCIPAL COLLABORATOR: University of Antwerp MICA (Mol

: Imaging Center Antwerp)
NAME: 1311 SapC-DOPS

. IP: US 7,877,783 B2, US 8,778,303B2, Ch tent
INDICATION: glioblastoma (brain cancer) res : ee ee

. ee : CN102014970B, European approved 2017. These
STAGE OF DEVELOPMENT: Preclinical. Seeking partner. patents are secure through 2029 in US, EU and China. MTTI obt
PRINCIPAL COLLABORATOR: University of Cincinnati

IP: pending an exclusive license from the
i : ‘ ; Medical College of Wisconsin.
co eING: Dae meraing rary Ne . ; ; . FUNDING: Obtained ~$1 million non-dilutive grants from NIH & E
OWNERSHIP: MTTI is establishing an option agreement with University of | QyNERSHIP: MTT!
Cincinnat :

http:/Avww.mt t.com/mm5/pdfs/pipeline/TDURA. pdf
hitp://www.mtarget.com/mm35/pdfs/pipeline/Glioblastoma.pdf B a B

NAME: LeishCure
INDICATION: Cutaneous Leishmaniasis (CL) aes : :
STAGE OF DEVELOPMENT: Preclinical. Seeking partner. CLASS: Diagnostic Spray for Guided Surgery

NAME: CypH

PRINCIPAL COLLABORATOR: University of Notre Dame (UND) INDICATION: Ovarian cancer surgery

. : : 7 : STAGE OF DEVELOPMENT: Preclinical. Seeking partner.
ea ere econ PRINCIPAL COLLABORATOR: Cornell Medical College

FUNDING: Obtained funding from NIAID. ge. Jeeps il # ee Hospital, Houston, Texa
OWNERSHIP: MTTVUND : Secured funding from

http://Awww.mtarget.com/mm5/pdfs/pipeline/Asset%20LeishCure.pdf tb alia MTT! is establishing an option agreement with Me

http:/Avwww.mtarget.com/mm95/pdfs/pipeline/Asset?o20CypH pdf

REL0000023692

From: Joe Allen [jallen@allen-assoc.com]

Sent: 3/13/2018 3:07:56 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]; Hammersla, Ann
(NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=87fb28aa23744cOb855ef0683ac2e8b4-hammersiaa]

Subject: KEI using King language, misrepresentation of march in rights in letter to USTR on compulsory licenses

Of course, Bayh-Dole has never been used as implied in the highlighted paragraph below, but why let facts get
in the way of a good story:

(htt

KEI testimony at March 8, 2018 USTR Special 301
hearing, focusing on US compulsory licensing of
patents

s://www.keionline.org/27147)

Posted on March 8, 2018 by James Love

On March 8, 2018, USTR and the interagency committee on the Special 301 held a hearing. KEI was one of the
groups testifying. More on this process here: https://keionline.org/ustr/special301

I began our oral testimony discussing President Trump’s promise, during the election, to negotiate lower prices
on drugs for Medicare, noting that many of the comments by PhRMA and other drug company lobby groups
would create norms that would make it impossible for President Trump to deliver on even a small fraction of his
promised savings.

I then read the following comments about compulsory licensing.

(more on compulsory licensing here: https://keionline.org.cl)

Compulsory licensing

PhRMA and other groups lobbying on behalf of big drug companies frequently target the use of compulsory
licensing as a “harmful IP-related trade barrier”.

KEI sees compulsory licenses as an important and underutilized tool to address excessive pricing and restrictive
licensing practices.

I would like to take a minute to provide some context for this proceeding.

First, the United States has at least 15 separate statutes that are used to permit non-voluntary use of patents, not
counting our various exceptions to patent rights for research or uses by medical professionals.

Second, the United States is by far, and I mean by far, the most frequent user of compulsory licenses. USTR

itself overturned an injunction on the importation of iPhones and iPads that infringed on patents owned by
Samsung, on August 3, 2013.[1]

RELO000023693

Under the Supreme Court eBay Doctrine regarding the enforcement on injunctions, courts routinely permit
infringement of patents, when royalties are paid to the patent holder. For another example involving Apple: in
2017, Apple successfully asked a judge for permission to use, without a voluntary license but subject to an
ongoing royalty, U.S. Patent No. 5,781,752, titled “Table based data speculation circuit for parallel processing
computer.[2]

The compulsory licenses under the eBay doctrine are fairly common, about one a month for a while, but now
less frequent as parties tend to grant voluntary licenses, when it is perceived to be hard to enforce an injunction,
and they cover a wide range of technologies.

In the area of medical technologies, the most common compulsory licenses ordered by the courts are for
medical devices and diagnostics, of which there are many, on everything from contact lenses to artificial heart
valves to diagnostic technologies. Often the companies requesting such compulsory license are innovators
themselves.

For example, in 2008, Abbott used the eBay doctrine to obtain a license to HCV Genotyping testing patents.
Similar compulsory licensing efforts were successful in several high income countries, including Germany,
where Roche was requesting the compulsory license, and in Australia and the UK, to mention a few other
countries.

The United States has also used the threat of compulsory licensing to force more liberal licensing or price
discounts, in cases where the federal government was a funder of research, including the patents on
reverse genetics needed to manufacture vaccines for the Avian flu, the stem cell patents held by WARF,
the Abbott patents on ritonavir, and the Fabry patents now held by Sanofi, to mention a few cases under
the Bayh-Dole Act. In 2016, 51 members of Congress asked the federal government to make more
frequent use of this Act.[3]

Recently 18 members of Congress asked the federal government to use 28 USC 1498 to grant compulsory
licenses on patents on HCV drugs, and the Senate Armed Services Committee in 2017 adopted a directive
to the Department of Defense to use compulsory licenses when prices on Army-funded drugs like Xtandi
are more expensive in the United States than in other high income countries.

Many persons, including President Trump, have called for changes in the law to allow Medicare to negotiate
drug prices. If Medicare negotiates drug prices, it will involve a threat, by the United States, to withhold
reimbursement, narrow formularies or increase co-payments. All of these measures hurt patients. We want the
Congress to give the government more robust authority to use compulsory licensing, in order to protect patients,
effectively putting the monopoly at risk rather than the patient, when there are disputes over prices.

KE] and others are planning to asking the Trump administration to use, under existing statutes, either or both 35
USC 203 and/or 28 USC 1498, to end monopolies, on at least three drugs, this calendar year. In every case there
are very significant abuses of patent rights, and negative consequences for patients.

Finally, we want to call attention to the growing patent thickets for two new important technologies, CRISPR
and CAR T. If we don’t have to ability to use compulsory licenses to force more liberal licensing of
technologies, it will harm innovation and make us defenseless from abusive pricing.

[1] Michael Froman’s decision in the Apple/Samsung ITC patent dispute and the USTR trade agenda, August 6,
2013, https://www.keionline.org/22282.

[2] Wisconsin Alumni Research Foundation v. Apple, Inc., Case: 3:14-cv-00062-wmce, (W.D. Wis., June 6,
2017).

RELO000023693

[3] 2016: 51 members of Congress have asked the NIH to use March-In rights to rein in high drug prices,
January 11, 2016. https:/(Awww.keionline.org/22983

Annex. US statutes that are used for compulsory licensing (non-
voluntary use) of patents.

35 U.S.C. 203 - MARCH-IN RIGHTS (Bayh-Dole Act)

35 U.S.C. 271(e)(6)(B) — INFRINGEMENT OF PATENT (biologic products where patents are not timely

disclosed)
35 U.S.C. 283 — INJUNCTION (under eBay doctrine)

28 USC 1498 — Patent and copyright cases (use by or for government)

30 U.S.C. 937 - CONTRACTS AND GRANTS (Black Lung disease)

42 USC Sec 2183 — Nonmilitary utilization (patents on atomic energy)

42 U.S.C. 7608 - MANDATORY LICENSING (Clean Air Act)

42 U.S.C. 16192 - NEXT GENERATION LIGHTING INITIATIVE

42 U.S.C. 17231 —- ENERGY STORAGE COMPETITIVENESS

19 U.S.C. 1337 - UNFAIR PRACTICES IN IMPORT TRADE (United States International Trade Commission)
Sherman Antitrust Act, 15 USC 1-7

15 U.S. Code § 1 — Trusts, etc., in restraint of trade illegal; penalty

15 U.S. Code § 2 — Monopolizing trade a felony; penalty

Wilson Tariff Act, 15 USC 8-11
15 U.S. Code § 8 — Trusts in restraint of import trade illegal; penalty

Clayton Act, 15 USC 12-27

15 U.S.C. 45 - UNFAIR METHODS OF COMPETITION UNLAWFUL; PREVENTION BY COMMISSION
(Federal Trade Commission)

=

James Love

James Love is the Director of Knowledge Ecology International. Previously, he was an economist for the Center
for Study of Responsive Law where he also directed the Consumer Project on Technology and the Taxpayer
Assets Project, Senior Economist for the Frank Russell Corporation, and held lecturer positions at Rutgers and
Princeton Universities. His KEI webpage is https://keionline.org/jamie.

More Posts Twitter Facebook

RELO000023693

Post navigation

Innogenetics v. Abbott — 2008 compulsory license granted for HCV genotyping kits under eBay v.
MercExchange

Chile Ministry of Health Takes Next Step Toward Compulsory License on HCV Drugs, Announces Public
Health Justifications

Joseph P. Allen
President

Allen and Associates
60704 Rt. 26, South
Bethesda, OH 43719
(W) 740-484-1814

(c) 304-280-2259
www.allen-assoc.com

RELO000023693

From: Baden, Elizabeth (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=BADENEM]

Sent: 3/13/2017 8:17:12 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]; Volkov, Marina (NIH/OD) [E]
[/O=NIH/OU=Nihexchange/cn=nimh/cn=mvolkov]

Subject: RE: edits to the Drug Pricing BRAIN brief

Attachments: Drug Pricing_v2.docx

Hi Mark,

loge sta teri Sesvcires eter leivenen arora Sreney Sears vesevenrerarmraralmlinenis lnemimscieieleraimbevai mtnimemsmetmest inner eeat

if you have a chance, please look at the attached version. My changes are tracked. If this look ok to you, then | can make
the changes in BRAIN.

Thanks!
Elizabeth

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, March 13, 2017 6:02 AM

To: Volkov, Marina (NIH/OD) [E] <mvolkov@od.nih.gov>
Cc: Baden, Elizabeth (NIH/OD) [E] <badenem @od.nih.gov>
Subject: Re: edits to the Drug Pricing BRAIN brief

KEI said last year it would appeal to the new HHS Sec'y on Xtandi, and they continue to object to proposed exclusive
licensing of specific technologies when public notice is made in FR. Pricing and exclusivity is a current public issue with
the Army's proposed Zika vaccine and NIAID is likely to get the same heat when they get to a point of licensing theirs.

With drug pricing issues continuing to fester and comments from the administration about addressing the high price of
drugs, we are likely to see more pressure at least from advocacy groups on this issue.

pietmreiereimsmimsmemimeeresscmrmemememememime Nem nmemnmememememememememimimememsmemierenrmre nee ete ERI RR RRR aan memimsmimemimemsmrmememimel

Sent from my iPhone

On Mar 12, 2017, at 8:49 PM, Volkov, Marina (NIH/OD) [E] <mvyoikev@od.nih.gov> wrote:

‘A * 2B

Hi Mark,

Dr. Tabak has made the following comment on the Drug Pricing BRAIN brief:

Any chance you can make these changes tomorrow (Monday)? Dr. Collins will be starting his study of the
briefs on Monday, so we need to wrap everything up by then.

RELO000023698

Thanks,

Marina

RELO000023698

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

Ee EP CRE ER ec BE PTE EP EN EE EEE SP EP PEE PERSE PESO oP EROS SEE IS RS EE ORNS POT OT Pa EP ET EOE RUE ETERS eee Sa OTE T Ee Ty Pree PE Pe

From: Rogers, Karen (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=B23EF4CA2FA14A6EB174EE611953A396-ROGERSK]

Sent: 2/28/2018 10:14:43 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Gottesman, Michael (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
{(FYDIBOHF23SPDLT)/cn=Recipients/cn=918c2344931542a592d00dbe83d3d5a3-gottesmm]

Subject: FW: ES - WF 370674 - FYI (CC)

Hi Mark ~ Since you mentioned this in our meeting this morning, | wanted to make sure that you were aware of this
DORMS notice. Looks like it has been assigned to NCI to respond. Regards, Karen

Naren L. Rogers

Acting Director

Office of Technology Transfer
National institutes of Health

6017 Executive Boulevard, Suite 325
Rockville, MD 20852

&-Mail: RogersK@nih.gov

Phone: 301-435-4359

Fax: 301-402-8878

SENSITIVE/CONFIDENTIAL INFORMATION

The attached information may be confidential. It is intended only for the addressee(s) identified above. If you are not the
addressee(s), or an employee or agent of the addressee(s), please note that any dissemination, distribution, or copying of
this communication is strictly prohibited. If you have received this e-mail in error, please destroy the document and notify
the sender of the error. Thank you.

From: EDRMS_NO_REPLY@mail.nih.gov [mailto:EDRMS_NO_REPLY@mail.nih.gov]

Sent: Wednesday, February 28, 2018 3:29 PM

To: Rogers, Karen (NIH/OD) [E] <rogersk@od.nih.gov>; White, Tracy (NIH/OD) [E] <whitever@od.nih.gov>; White, Tracy
(NIH/OD) [E] <whitever@od.nih.gov>

Subject: ES - WE 370674 - FYI (CC)

To whom it may concern:

Message from the Director's Document and Records Management System (DDRMS)

You have received a task notification requiring your attention.

Please do not reply to this email, this is an automated message.

If you have concerns please contact the NIH Help Desk at (301) 496-4357.

Work Folder Information
Work Folder: WF 370674

REL0000023704

Process: FYI

Program Analyst: Cramer, Lindsay (NIH/OD) [E]

Due Date:

WE Subject: Mr. Andrew Goldman writes to Dr. David Lambertson (NCI) and Dr. Collins to provide
Knowledge Ecology International’s (KEI) appeal of the NIH/NCI decision to proceed with the anti-CD30
license to Kite Pharma. This email is in response to Dr. Lambertson’s February 26 email responding to KEI’s
February 14 email requesting information on the formal appeal procedures.

IC: od_ott

From: Goldman, Andrew

To: Lambertson, DavidCollins, Francis

Remarks: FYI to OER, OIR, OTT, and OGC. Assigned to NCI for any necessary action. Thank you! -Lindsay

Additional instructions are included on the task form, click the link to open the Task

REL0000023704

From: Berkley, Dale (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=5EE461C29F5045A49FOADF82CAAA2F31-BERKLEYD]

Sent: 2/27/2018 9:12:51 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Jambou, Robert (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=ff42a9fa39824980aa9e36af49e56chc-jambour]; Jorgenson, Lyric (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3bbde7d361374981a4d336b6eeb17521-jorgensonla]

Subject: RE: FOIA Request -- Can you help?

Best, Dale

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, February 27, 2018 2:00 PM

To: Berkley, Dale (NIH/OD) [E] <berkleyd@od.nih.gov>

Cc: Jambou, Robert (NIH/OD) [E] <jambour@od.nih.gov>; Jorgenson, Lyric (NIH/OD) [E] <lyric.jorgenson@nih.gov>
Subject: RE: FOIA Request -- Can you help?

See below.

THanks,
Mark

From: Jambou, Robert (NIH/OD) [E]

Sent: Tuesday, February 27, 2018 1:45 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum@oc.nib.gov>; Jorgenson, Lyric (NIH/OD) [E] <ivric.jorgenson@inih.eov>
Subject: RE: FOIA Request -- Can you help?

OK thank you Mark.

Thanks se much!

REL0000023705

Bob J.

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, February 27, 2018 1:37 PM

To: Jorgenson, Lyric (NIH/OD) [E] <iyric.jorgenson@nih.gov>; Jambou, Robert (NIH/OD) [E] <jambour@eod.nih.gov>
Subject: RE: FOIA Request -- Can you help?

From: Jorgenson, Lyric (NIH/OD) [E]

Sent: Tuesday, February 27, 2018 1:32 PM

To: Jambou, Robert (NIH/OD) [E] <jambour@od.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum@od nih.goy>
Subject: RE: FOIA Request -- Can you help?

I’m meeting with CW in an hour. I'll make sure to bring it up with her as well. Mark — do you have a recommendation?

From: Jambou, Robert (NIH/OD) [E]

Sent: Tuesday, February 27, 2018 1:28 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rehrbaum @od.-nib.gov>
Ce: Jorgenson, Lyric (NIH/OD) [E] <iyric.jorgenson@nih.gov>
Subject: FOIA Request -- Can you help?

Hi Mark & Lyric,

We have received a FOIA request from Andrew S. Goldman of Knowledge Ecology International (KEI -- see items
attached “Request for documents for OSP request” and therein “Request 47590.pdf”). The formal request consists of
four aggregated requests.

The instructions from the FOIA office per Roger Bordine =

Any guidance you can provide on how to proceed with this request would be greatly appreciated.
Thanks...

Bob J.

REL0000023705

From: Jambou, Robert (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=FF42A9FA39824980AA9E36AF49ES6CBC-JAMBOUR]

Sent: 2/27/2018 6:27:30 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Jorgenson, Lyric (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=3bbde7d361374981a4d336b6eeb17521-jorgensonla]

Subject: FOIA Request -- Can you help?

Attachments: Request for documents for OSP request

Hi Mark & Lyric,
We have received a FOIA request from Andrew S. Goldman of Knowledge Ecology International (KEI -- see items

attached “Request for documents for OSP request” and therein “Request 47590.pdf”). The formal request consists of
four aggregated requests.

Any guidance you can provide on how to proceed with this request would be greatly appreciated.
Thanks...

Bob J.

REL0000023706

From: Sullivan, Nicholle (NIH/NHLBI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=49A1E4D7663F48A39B2D953804DDBFB8-SULLIVANN]
Sent: 2/26/2018 8:37:30 PM

To: Jambou, Robert (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=ff42a9fa39824980aa9e36af49e56cbc-jambour]
Subject: Request for documents for OSP request

Attachments: NIH FOIA Request for Direct - Goldman (OSP) - (Aggregate 4 requests into 1 request).pdf; Request 47590. pdf

Flag: Follow up
Hi Bob,

We received the attached FOIA Requests for any and all documents seeking antitrust advice under 40 USC section 559
for specified date ranges: 1) January 1, 2000 to the present; 2) the year 1979; 3) the year 1984 and 4) the year
1994from the period of January 1, 1979 to December 31, 1979. 40 U.S.C. § 559 concerns the obligation of Federal
Agencies to seek and obtain antitrust advice from the Attorney General prior to the disposal of property, including
patents, to private interests.

The requester is specifically interested in any documents which discuss the obligations of NIH, including any of its
institutes and centers, with regard to seeking antitrust advice in the context of licensing federally-owned and/or
federally-funded inventions.

The FOIA requests will be aggregated into one OSP request per the attached email. Please conduct a search for
responsive records and if you could, please give me an idea of how the search is going.

Thanks so much,
Nicholle

Nicholle Sullivan, J.D.

Lead Government Information Specialist

Freedom of Information and Privacy Act Branch OM/OD/NHLBI
6705 Rockledge Dr., Suite 6054

Bethesda, MD 20892-7957

301-496-9737 (office)

240-507-9935 (direct line)

301-402-3604 (fax)

sullivann@mail.nih.gov

REL0000023706.0001

From: Bordine, Roger (NIH/OD) [E

To: NHLBI FOIA REQUEST (NIH/NHLBI)
Ce: Manheim, Marianne (NIH/NHLBD [E]; NIH FOIA
Subject: NIH FOIA Request for Direct - Goldman (OSP) - (Aggregate 4 requests into 1 request)
Date: Thursday, February 22, 2018 12:21:00 PM
Attachments: 2369 _001.pdf
image001.png

paves ayaa eee oS EUR

Good Afternoon,

Please see the attached request for direct response regarding a copy of records related to the NIH’s
obligation to seek anti-trust advice from the Attorney General regarding federally owned or funded
inventions.

Thank you.

Roger Bordine

Program Assistant

Freedom of Information Office
National Institutes of Health
Building 31, Room 5B35

31 Center Drive

Bethesda, MD 20892

Phone: 301-496-5633
Fax: 301-402-4541

Roger bordine@niki gov

REL0000023706.0001.0001

Freedom OF Information Act Tracking System (FOJA) Page 1 of 1

Goldman

DATE: 2/22/2018

TO: Marianne Manheim
NHLBI FOIA Coordinator
Building Rockledge 1, Rm. 6182
6705 Rockledge Drive
Bethesda, MD 20892

FROM: NIH FOIA Office, OD/OCPL
SUBJECT: FOIA Log No. 2018/052

The attached FOIA request is forwarded to you for the following action:

FOR DIRECT REPLY. Enter the case into the FOIA Tracking System. Upon
completion, please complete the Close-Out, and if there is an invoice, please send a
copy of the invoice with the final letter to the NIH FOIA Office.

If you forward this request to a program office within your IC, keep a copy of this
request in your FOIA Case file. As the IC FOIA Coordinator, you are responsible for the
collection of records and follow-up until the request is closed.

Please contact the NIH FOIA Office on 301-496-5633 or at nin

Bria nibdey if you
have any questions.

COMMENTS: See Email (OSP)

https://foia.od.nih.gov/Requests/CoverMemo.aspx 2/22/2018
REL0000023706.0001.0001.0001

Bordine, Roger (NIH/OD) [E]

From: Andrew Goldman <andrew.goldman@keionline.org>

Sent: Wednesday, February 21, 2018 1:05 PM

Tao: NIH FOIA

Subject: Re: FOIA Request Re: NIH Seeking Antitrust Advice Under 40 US.C. § 559
Attachments: KE|_FOIA21Feb2018_NIH_40_USC_559.pdf; KEI_FOIA21Feb2018_NIH_40_USC_559 2. pdf.

KEI FOIA21Feb2018_NIH_40_USC_559 3 pdf; KEL FOIA2 1Feb2018_ NIH_40_ USC 559 _4 pdf

Dear Sir or Madam:

Yesterday | sent four related FOIA requests, but | unfortunately attached the incorrect requests. if you could please replace
those requests with the corrected versions attached, | would appreciate it.

Best,
Andy

Andrew 5. Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International

ance ns PELASG KEE
tel.: +1,202.332 2670
www. Ke re

On Tue, Feb 20, 2018 at 12:51 PM, Andrew Goldman <andrew.goldman@keion!
Dear Sir or Madam:

ire.ore> wrote:

Please find attached four related Freedom of Information Act requests from Knowledge Ecology International regarding the NIH's
obligations to seek antitrust advice under 40 USC § 559. The first is for the period January 1, 2000 to the present; the second is for the
year of 1979; the third is for the year of 1984; and the fourth is for the year of 1994.

Thank you in advance for your attention to this request.

Sincerely,

Andrew $. Goldman

Counsel, Policy and Legal Affairs
Knowledge Ecology international
tel.:
wiv keto

REL0000023706.0001.0001.0001

FROM: Andrew S. Goldman

clo Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35
31 Center Drive, MSC 2107
Bethesda, MD 20892-2107 a
nihfoia@mail.nih.gov Al A D

DATE: February 21, 2018

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559

Dear FOIA Officer:

Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
Part 5), Knowledge Ecology International (KEI) requests any and all documents, from the period
of January 1, 1979 to December 31, 1979, related to 40 U.S.C. § 559.

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private
interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.

Request for Full Waiver of Fees

Knowledge Ecology International (KEI) requests a full waiver of fees under the Freedom of
Information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines.

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:

REL0000023706.0001.0001.0001

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purpogées,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
fo public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.4. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our attempt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).

REL0000023706.0001.0001.0001

2.1. § 5.54(b)(2){ii): The disclosure must contribute to the understanding of a reasonably broad
audience of persons interested in the subject, as opposed to the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers; patients and
caretakers; policy experts; and people who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KE] operates a website (https://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KEI will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
* 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

@ 19 September 2016, “500+ Pages of Documents on NFL Attempts fo Influence NIH
Funding of Concussion Studies,” https://keionline.org/node/2630

e 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KEI does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0001.0001

# 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http:/Avww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

e® 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b) (3): The disclosure must not be primarily in the commercial interest of the requester.

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We request the identification of any withheld records with specificity, including descriptions of
the withheld material in detail, the specific statutory exemption or basis for denial, the reasons
that the statutory exemption or denial applies in this instance, and the interests that would be

foreseeably harmed by disclosure of the record.

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

If possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legai Affairs
Knowledge Ecology International
+1.202.332.2670

REL0000023706.0001.0001.0001

andrew.goldman@keionline.org

REL0000023706.0001.0001.0001

FROM: Andrew S. Goldman

clo Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35
31 Center Drive, MSC 2107
Bethesda, MD 20892-2107
nihfoia@mail.nih.gov

DATE: February 21, 2018

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559

Dear FOIA Officer:

Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
Part 5), Knowledge Ecology International (KE!) requests any and all documents, from the period
of January 1, 1984 to December 31, 1984, related to 40 U.S.C. § 559.

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private
interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.

Request for Full Waiver of Fees

Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of
information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines.

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:

REL0000023706.0001.0001.0001

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purposes,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
to public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our attempt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).

REL0000023706.0001.0001.0001

2.1. § 5.54(b)(2)(ii): The disclosure must contribute to the understanding of a reasonably broad
audience of persons interested in the subject, as opposed to the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers; patients and
caretakers; policy experts; and people who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KEI operates a website (https://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KEI will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
# 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

# 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH
Funding of Concussion Studies,” https://keionline.org/node/2630

* 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KE] works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KE! does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0001.0001

@ 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http:/Awww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

@ 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
https:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

# 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester,

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We request the identification of any withheld records with specificity, including descriptions of
the withheld material in detail, the specific statutory exemption or basis for denial, the reasons
that the statutory exemption or denial applies in this instance, and the interests that would be

foreseeably harmed by disclosure of the record.

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

If possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for.records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legal Affairs
Knowledge Ecology International
+1,202.332,.2670

REL0000023706.0001.0001.0001

andrew.goldman@keionline.org

REL0000023706.0001.0001.0001

FROM: Andrew S. Goldman

c/o Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35
31 Center Drive, MSC 2107
Bethesda, MD 20892-2107
nihfoia@mail.nih.gov

DATE: February 21, 2018

Fel 4 Josh

i

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40

U.S.C. § 559

Dear FOIA Officer:

Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
Part 5), Knowledge Ecology International (KE!) requests any and all documents, from the period

of January 1, 1994 to December 31, 1994, related to 40 U.S.C. § 559.

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private

interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of

licensing federally-owned and/or federally-funded inventions.

Request for Full Waiver of Fees

Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of

Information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable

access to affordable medicines.

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public

interest:

REL0000023706.0001.0001.0001

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purposes,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
to public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our attempt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (Sth. Cir. 1987) (citations omitted).

REL0000023706.0001.0001.0001

2.1. § §.54(b)(2) (ii): The disclosure must contribute to fhe understanding of a reasonably broad
audience of persons interested in the subject, as opposed to the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers: patients and
caretakers; policy experts; and peaple who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KE! operates a website (httos://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KE] will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

# 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
# 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

e 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH
Funding of Concussion Studies,” https://keionline.org/node/2630

@ 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KEI does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0001.0001

* 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http:/Avwww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

* 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester.

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We request the identification of any withheld records with specificity, including descriptions of
the withheld material in detail, the specific statutory exemption or basis for denial, the reasons
that the statutory exemption or denial applies in this instance, and the interests that would be

foreseeably harmed by disclosure of the record.

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A){i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

If possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legal Affairs
Knowledge Ecology International
+4.202.332.2670

REL0000023706.0001.0001.0001

andrew.goldman@keionline.org

REL0000023706.0001.0001.0001

FROM: Andrew S. Goldman

clo Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35
31 Center Drive, MSC 2107
Bethesda, MD 20892-2107
nihfoia@mail.nih.gov

DATE: February 21, 2018

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559

Dear FOIA Officer:

Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
Part 5), Knowledge Ecology International (KEI) requests any and all documents, from the period
of January 71, 2000 to the present, related to 40 U.S.C. § 559.

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private
interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.

Request for Full Waiver of Fees

Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of
information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines.

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit
public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:

REL0000023706.0001.0001.0001

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purposes,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § §.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
to public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our attempt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).

REL0000023706.0001.0001.0001

2.1. § 5.54(b)(2) (i): The disclosure must contribute to the understanding of a reasonably broad
audience of persons interested in the subject, as opposed fo the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers; patients and
caretakers; policy experts; and people who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KE] operates a website (https://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KEI will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
# 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

# 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH
Funding of Concussion Studies,” hitps://keionline.org/node/2630

# 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KE! works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KEI does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0001.0001

e 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http:/Avww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
https:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

e 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester.

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We request the identification of any withheld records with specificity, including descriptions of
the withheld material in detail, the specific statutory exemption or basis for denial, the reasons
that the statutory exemption or denial applies in this instance, and the interests that would be

foreseeably harmed by disclosure of the record.

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

If possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legal Affairs
Knowledge Ecology International
+1.202,332.2670

REL0000023706.0001.0001.0001

andrew.goldman@keionline.org

REL0000023706.0001.0001.0001

National Institutes of Health

Fe uy DNacovery Aibe Aealtls

REL0000023706.0001.0001.0002

Freedom OF Information Act Tracking System (FOIA) Page | of 1

DATE: 2/22/2018

TO: Marianne Manheim
NHLBI FOIA Coordinator
Building Rockledge 1, Rm. 6182
6705 Rockledge Drive
Bethesda, MD 20892

FROM: NIH FOIA Office, OD/OCPL
SUBJECT: FOIA Log No. 2018/052

The attached FOIA request is forwarded to you for the following action:

FOR DIRECT REPLY. Enter the case into the FOIA Tracking System. Upon
completion, please complete the Close-Out, and if there is an invoice, please send a
copy of the invoice with the final letter to the NIH FOIA Office.

If you forward this request to a program office within your IC, keep a copy of this
request in your FOIA Case file. As the IC FOIA Coordinator, you are responsible for the
collection of records and follow-up until the request is closed.

Please contact the NIH FOIA Office on 301-496-5633 or at silt
have any questions.

dmailnih.aeyv if you

COMMENTS: See Emai

https://foia.od.nih.gov/Requests/CoverMemo.aspx 2/22/2018
REL0000023706.0001.0002

From: Andrew Goldman <andrew.goldman@keionline. org>

Sent: Wednesday, February 21,2018 1:05 PM
To: NIH FOIA
Subject: Re: FO! Seeki Advice Under 40 U.S.C. § 559

Attachments:

Dear Sir or Madam:

Yesterday | sent four related FOIA requests, but | unfortunately attached the incorrect requests. If you could please replace
those requests with the corrected versions attached, | would appreciate it.

Best,
Andy

Andrew & Goldman

Counsel, Policy and Legal Affairs
Knowledge Ecology International

andrew golden @teioniine ore // www.
tel.

miter comyAsG KE!

Fa

On Tue, Feb 20, 2018 at 12:51 PM, Andrew Goldman <andrew.goldman@keionline.org> wrote:
Dear Sir or Madam:

Thank you in advance for your attention to this request.

Sincerely,

Andrew §, Goldman
Counsel, Policy and Legal Affairs
Knowledge Ecology International

tel: £1,202.
wow. keloaline.org

REL0000023706.0001.0002

FROM: Andrew S. Goldman

clo Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35
31 Center Drive, MSC 2107
Bethesda, MD 20892-2107 -
nihfoia@mail.nih.gov Ab Rips

DATE: February 21, 2018

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559

Dear FOIA Officer:

Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
5), Knowledge Ecology International (KE) :

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private
interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.

Knowledge Ecology International (KEI) requests a full waiver of fees under the Freedom of
Information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines.

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit

public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:

REL0000023706.0001 .0002

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purpogés,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
fo public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our atternpt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).

REL0000023706.0001.0002

2.1. § 5.54(b)(2){ii): The disclosure must contribute to the understanding of a reasonably broad
audience of persons interested in the subject, as opposed to the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers; patients and
caretakers; policy experts; and people who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KE] operates a website (https://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KEI will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
* 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

@ 19 September 2016, “500+ Pages of Documents on NFL Attempts fo Influence NIH
Funding of Concussion Studies,” https://keionline.org/node/2630

e 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KEI does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0002

# 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http:/Avww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

e® 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b) (3): The disclosure must not be primarily in the commercial interest of the requester.

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

lf possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legai Affairs
Knowledge Ecology International
+1.202.332.2670

REL0000023706.0001.0002

andrew.goldman@keionline.org

REL0000023706.0001.0002

FROM: Andrew S. Goldman

cio Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35
31 Center Drive, MSC 2107
Bethesda, MD 20892-2107
nihfoia@mail.nih.gov

DATE: February 21, 2018

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559

Dear FOIA Officer:

Under the Freedam of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
Part 5), Knowledge Ecology International (KE!) feques

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private
interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.

Request for Full Waiver of Fees

Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of
information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines.

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit

public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:

REL0000023706.0001.0002

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purposes,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
to public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.1. § §.54(b)(2){i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our atternpt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).

REL0000023706.0001.0002

2.1. § 5.54(b) (2) (ii): The disclosure must contribute to the understanding of a reasonably broad
audience of persons interested in the subject, as opposed to the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers; patients and
caretakers; policy experts; and people who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KEI operates a website (https://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KEI will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
# 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

# 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH
Funding of Concussion Studies,” https://keionline.org/node/2630

# 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KE] works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KE! does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0002

@ 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http:/Awww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

@ 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
https:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

# 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester,

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We request the identification of any withheld records with specificity, including descriptions of
the withheld material in detail, the specific statutory exemption or basis for denial, the reasons
that the statutory exemption or denial applies in this instance, and the interests that would be

foreseeably harmed by disclosure of the record.

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

If possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for.records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legal Affairs
Knowledge Ecology International
+1,202.332,.2670

REL0000023706.0001.0002

andrew.goldman@keionline.org

REL0000023706.0001.0002

FROM: Andrew S. Goldman

c/o Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35 j
31 Center Drive, MSC 2107 Hl
Bethesda, MD 20892-2107 \
nihfoia@mail.nih.gov

DATE: February 21, 2018

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559

Dear FOIA Officer:

Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
Part 5), Knowledge Ecology International (KEI) reques

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private
interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.

Request for Full Waiver of Fees

Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of
Information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines,

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit

public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:

REL0000023706.0001.0002

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purposes,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § 5.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
to public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our attempt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (Sth. Cir. 1987) (citations omitted).

REL0000023706.0001.0002

2.1. § §.54(b)(2) (ii): The disclosure must contribute to fhe understanding of a reasonably broad
audience of persons interested in the subject, as opposed to the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers: patients and
caretakers; policy experts; and peaple who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KE! operates a website (httos://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KE] will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

# 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
# 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

e 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH
Funding of Concussion Studies,” https://keionline.org/node/2630

@ 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KEI works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KEI does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0002

* 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http:/Avwww.thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
hitps:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

* 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester.

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We request the identification of any withheld records with specificity, including descriptions of
the withheld material in detail, the specific statutory exemption or basis for denial, the reasons
that the statutory exemption or denial applies in this instance, and the interests that would be

foreseeably harmed by disclosure of the record.

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A){i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

If possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legal Affairs
Knowledge Ecology International
+4.202.332.2670

REL0000023706.0001.0002

andrew.goldman@keionline.org

REL0000023706.0001.0002

FROM: Andrew S. Goldman

clo Knowledge Ecology International
1621 Connecticut Ave NW Suite 500
Washington, DC 20009
andrew.goldman@keionline.org

TO: FOIA Officer

FOIA Information Office

NIH Building 31, Room 5B35
31 Center Drive, MSC 2107
Bethesda, MD 20892-2107
nihfoia@mail.nih.gov

Qe 852

DATE: February 21, 2018

RE: Freedom of Information Act Request Regarding NIH Seeking Antitrust Advice Under 40
U.S.C. § 559

Dear FOIA Officer:

Under the Freedom of Information Act (5 U.S.C. § 552) and relevant NIH regulations (45 CFR
Part 5), Knowledge Ecology International (KE

40 U.S.C. § 559 concerns the obligation of Federal Agencies to seek and obtain antitrust advice
from the Attorney General prior to the disposal of property, including patents, to private
interests.

We are specifically interested in any documents which discuss the obligations of NIH, including
any of its institutes and centers, with regard to seeking antitrust advice in the context of
licensing federally-owned and/or federally-funded inventions.

Request for Full Waiver of Fees

Knowledge Ecology International (KE!) requests a full waiver of fees under the Freedom of
information Act and under 45 CFR Part 5.54.

KEI is a 501(c)(3) non-profit organization that promotes the public interest in ensuring equitable
access to affordable medicines.

Congress enacted the current FOIA fee waiver provisions to protect the interests of non-profit

public interest groups, such as KEI, that seek to disseminate information that is in the public
interest:

REL0000023706.0001.0002

“The waiver provision was added to FOIA ‘in an attempt to prevent government agencies
from using high fees to discourage certain types of requesters and requests,’ in a clear
reference to requests from journalists, scholars and, most importantly for our purposes,
nonprofit public interest groups.” Better Gov't Ass'n v. Department of State, 780 F.2d 86,
94 (D.C. Cir. 1986) (citations omitted).

Disclosure of the requested information is in the public interest because it is likely to contribute
significantly to public understanding of the operations or activities of the Government.

1. § 5.54(b)(1): “Disclosure of the requested information would shed light on the operations or
activities of the government.”

Disclosure of the requested records would shed light on the operations and activities of the
federal government with regards to 40 U.S.C. § 559, particularly with regard to obligations
federal agencies have in seeking antitrust advice in the context of licensing federally-owned
patents. In evaluating this factor, “reasonable specificity” is “all that FOIA requires.” Judicial
Watch v. Rossotti , 326 F.3d 1309, 1313 (D.C. Cir. 2003).

2. § §.54(b)(2): Disclosure of the requested information would be likely to contribute significantly
to public understanding of those operations or activities.

This factor is satisfied because the following criteria are met.

2.1. § 5.54(b)(2)(i): Disclosure of the requested records must be meaningfully informative about
government operations or activities.

Disclosure of the requested records would be meaningfully informative about government
operations and activities because it would reveal information that is not yet in the public domain.
In particular it would provide information regarding whether the National Institutes of Health is
abiding by the law when licensing medical technologies that have received federal funding. This
information would be helpful in informing policy discussions regarding the public interest and the
disposal of federal property.

As mentioned previously, the information is not publicly available and our attempt to seek that
information from the NIH was denied.

“Legislative history suggests that information has more of this potential [to contribute to public
understanding] to the degree that the information is new and supports public oversight of
agency operations, including the effect of agency policy on public health.” McClellan Ecological
Seepage Situation v. Carlucci , 835 F.2d 1282, 1286 (9th. Cir. 1987) (citations omitted).

REL0000023706.0001.0002

2.1. § 5.54(b)(2) (i): The disclosure must contribute to the understanding of a reasonably broad
audience of persons interested in the subject, as opposed fo the individual understanding of the
requester.

The subject of the request concerns government operations and activities related to the antitrust
ramifications of the licensing of federally-owned and federally-funded patents, including on
medical technologies, and is intertwined with policy discussions affecting the prices of
prescription drugs in the United States.

There is a broad audience of persons interested in the subject, including, inter alia, advocates
for affordable access to medicines; doctors, nurses, and other medical providers; patients and
caretakers; policy experts; and people who purchase insurance or other forms of medical care.
Disclosure would contribute to the understanding of that broad audience of persons because it
would provide context for the policies, positions, and decisions of the National Institutes of
Health related to federal R&D funding and its approach to drug pricing issues.

KEI is an NGO that works on drug pricing and access to medicines, and has expertise in public
health, drug pricing, and access to medicines.

KEI has the ability and intention to effectively convey the information contained in the requested
records to the public. KE] operates a website (https://keionline.org) which hosts an extensive
archive that is regularly consulted by advocates, academics, and the press. KEI will review the
requested records and produce a clear and concise analysis of those records. KEI will use
social media and listservs to distribute that analysis to the broad audience of persons interested
in the subject of the request.

KEI regularly publishes and analyzes records requested under the FOIA on its website,
including recently on various government operations and activities at parts of DHHS:

* 28 February 2017, “CDC FOIA shows US, WHO opposed request to discuss UNSG's
High-Level Panel on Access to Medicines Report at EB,” https://keionline.org/node/2727
# 18 October 2016, “Kite Pharma Uses CRADAs to Conduct Important Clinical Research
on New Cancer Treatments,” https://keionline.org/node/2640

# 19 September 2016, “500+ Pages of Documents on NFL Attempts to Influence NIH
Funding of Concussion Studies,” hitps://keionline.org/node/2630

# 16 September 2016, “NIH Waivers for U.S. Manufacturing Requirements for
Federally-Funded Drugs,” https://keionline.org/node/2629 Additionally, KE! works closely
with journalists to provide analysis for documents requested by KEI under the FOIA.

KEI does not merely distribute documents to journalists, but provides in-depth analysis that later
becomes the basis for stories:

REL0000023706.0001.0002

e 3 March 2017, Vidya Krishnan, “U.S. nixed India’s plea on reforms in medicine,” The
Hindu, http://www. thehindu.com/news/national/us-nixed-indias-plea-on-reforms-in-medici
ne/article17403526.ece

# 31 December 2016, Dan Vergano, “If Taxpayers Invent A Drug, Should The
Government Just Give It Away?,” Buzzfeed News,
https:/Awww.buzzfeed.com/danvergano/nih-drug-giveaway

e 20 December 2016, “Front page New York Times story explores Kite Pharma's
profitable relationship with NIH regarding expensive cancer drug,”
https://keionline.org/node/2703

3. § 5.54(b)(3): The disclosure must not be primarily in the commercial interest of the requester.

Knowledge Ecology International is a non-profit 501(c)(3) organization that does not have any
commercial, trade, or profit interest in disclosure of the requested records.

Other

We request the identification of any withheld records with specificity, including descriptions of
the withheld material in detail, the specific statutory exemption or basis for denial, the reasons
that the statutory exemption or denial applies in this instance, and the interests that would be

foreseeably harmed by disclosure of the record.

We look forward to your acknowledgement of this request within 10 working days and your final
determination within 20 working days. 5 U.S.C. § 552(a)(6)(A)(i). Please inform us of any
unusual circumstances that would require you to extend the 20-day statutory time limit, “setting
forth the unusual circumstances for such extension and the date on which a determination is
expected to be dispatched.” 5 U.S.C. § 552(a)(6)(B)(i).

If possible, please conduct all correspondence by email and disclose all records via electronic
copy. Please contact me if you have any questions about our request for records or if you
require additional information in support of our request for a fee waiver. Thank you in advance
for your assistance.

Sincerely,

Andrew S. Goldman, Esq.
Counsel, Policy and Legal Affairs
Knowledge Ecology International
+1.202.332.2670

REL0000023706.0001.0002

andrew.goldman@keionline.org

REL0000023706.0001.0002

From: Pollard, Ricquita (NIH/NCI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DC946982E43F43CB925773EA52C40AFA-POLLARDRD]
Sent: 8/29/2018 9:58:49 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Chatterjee, Sabarni (NIH/NCI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=f4520fc058d6457aac24b57685235b12-chatterjees]

Subject: RE: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development and

Commercialization of Cancer Immunotherapy, per 83 FR 35665
Attachments: Response to KEl_comments on A-311-2018 082018.docx

Hi Mark,

Attached please find additional details in the response to KEI. If you have time to discuss over the phone, please let me
know.

Thanks,
Ricquita

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, August 21, 2018 4:18 PM

To: Pollard, Ricquita (NIH/NCI) [E] <ricquita.pollard@nih.gov>

Cc: Chatterjee, Sabarni (NIH/NCI) [E] <sabarni.chatterjee@nih.gov>

Subject: RE: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development and
Commercialization of Cancer Immunotherapy, per 83 FR 35665

From: Pollard, Ricquita (NIH/NCI) [E]

Sent: Tuesday, August 21, 2018 1:03 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Cc: Chatterjee, Sabarni (NIH/NCI) [E] <sabarni.chatterjee@nih.gov>

Subject: FW: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development and
Commercialization of Cancer Immunotherapy, per 83 FR 35665

Hi Mark,

| am processing a Start-Up Exclusive License application (A-311-2018) from Midissia Therapeutics for a cancer
immunotherapy. The Federal! Register Notice for this application (attached) was posted on July 27“ and the comment
period according to the notice ended August 13°. | received an email from James Love and Manon Ress on August
13" (see below) with comments from Knowledge Ecology International (KEI) and the Union for Affordable Cancer
Treatment (UACT) addressing four topics: 1) No discrimination against US residents in pricing, 2) Reduce term of
exclusivity when revenues are large, 3) Developing countries, and 4) Transparency.

Please see my proposed response in the attached WORD document. If you have any questions or concerns, please let
me know.

Thanks,

REL0000023802

Ricquita

Ricquita D. Pollard, Ph.D.

Technology Transfer Manager

Technology Transfer Center

National Cancer Institute

9609 Medical Center Drive, Rm 1-E530
Bethesda, MD 20892-9702 (for business mail)
Rockville, MD 20850-9702 (for courier service/visitors)
Phone (Main Office): (240) 276-5530

Direct Phone: (240) 276-5490

Fax: (240) 276-5503

pollardrd@mail.nih.gov

https://ttc.nci.nih.gov/index.ph

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure, copying or
use of this email or the information enclosed therein is strictly prohibited, and you should notify the sender for return of
any attached documents.

From: James Love <james.love@keionline.org>

Sent: Monday, August 13, 2018 11:48 PM

To: Pollard, Ricquita (NIH/NCI) [E] <ricquita.pollard@nih.gov>

Subject: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development and
Commercialization of Cancer Immunotherapy, per 83 FR 35665

August 13, 2018

Ricquita Pollard, Technology Transfer Manager,
NCI Technology Transfer Center,

Via Email: pollardrd@mail.nih.gov.

Re: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development
and Commercialization of Cancer Immunotherapy, per 83 FR 35665

Dear Ricquita Pollard:

The following are comments from Knowledge Ecology International (KE!) and the Union for Affordable
Cancer Treatment (UACT), on the proposed exclusive license for patents noticed in the Federal
Register for a license to Midissia Therapeutics (“Midissia”) located in San Francisco, California.

1. No discrimination against US residents in pricing

We ask that the NIH include language in the proposed exclusive license to ensure that the prices in
the U.S. for any drug, vaccine, medical device or other health technology using the inventions are not
higher than the median price charged in the seven countries with the largest gross domestic product

(GDP), that also have a per capita income of at least 50 percent of the United States, as measured by
the World Bank Atlas Method.

We consider this a modest request to protect U.S. residents, who paid for the R&D that created the
licensed inventions.

2. Reduce term of exclusivity when revenues are large

REL0000023802

In addition to an external reference pricing test, we propose that the exclusivity of the license in the
U.S. should be reduced when the global cumulative sales from products or services using the
inventions exceed certain benchmarks.

Given the modest cost of acquiring an NIH patented invention, the amount of money the developer
needs in sales to justify additional investments in R&D is reduced, as compared to cases where a
company developes or acquires the technology from non government sources.

This request is consistent with the statutory requirements of 35 USC 209, which requires that “the
proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for
bringing the invention to practical application.”

One possible implementation of revenue benchmarks is as follows: exclusivity will be reduced by one
year for every $500 million in revenue equivalents, earned after the first $1 billion, where revenue
equivalent is defined as global cumulative sales plus market entry rewards as well as government
grants or tax credits, for the product or products using the invention. However, the NIH could choose
different benchmarks, so long as the limits on exclusivity address the requirements of 35 USC 209,
that the incentive is “not greater than reasonably necessary.”

3. Developing countries

We are concerned that several NIH funded inventions are not accessible in developing countries, due
to prices that are high and not affordable in markets where per capita incomes are significantly lower
than the United States. For this reason, we ask the NIH to limit the exclusivity in the license to

countries that have per capita incomes that are at least 30 percent of the United States.

We also ask the NIH to reach out to the Medicines Patent Pool (MPP), in order to enter into an
agreement that gives the MPP an option to negotiate non-exclusive open licenses for the inventions
in developing countries.

4. Transparency

The licensee should be required to file an annual report to the NIH, available to the public, on the
research and development (R&D) costs associated with the development of any product that uses the
inventions, including reporting separately and individually the outlays on each clinical trial. We will
note that this is not a request to see a company business plan or license application. We are asking
that going forward the company be required to report on actual R&D outlays to develop the subject
inventions. Reporting on actual R&D outlays is important for determining if the NIH is meeting the
requirements of 35 USC 209, that “the proposed scope of exclusivity is not greater than reasonably
necessary to provide the incentive for bringing the invention to practical application.” Specifically,
having data on actual R&D outlays on each clinical trial used to obtain FDA approval provides
evidence that is highly relevant to estimating the risk adjusted costs of bringing NIH licensed
inventions to market.

Sincerely,

James Love
Knowledge Ecology International

REL0000023802

Manon Anne Ress
Union for Affordable Cancer Treatment

James Love. Knowledge Ecology International
http://www.keionline.org/donate.htm|
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile: +41.76.413.6584, twitter.com/jamie_ love

REL0000023802

August 29, 2018

James Love

Scientific and Technical Advisor
Knowledge Ecology International
Manon Anne Ress

Union for Affordable Cancer Treatment

IN RE: Your Letter Dated August 13, 2018 in response to 83 FR 35663, Published July 27, 2018
“Prospective Grant of Exclusive Patent License to Midissia Therapeutics for the Development and
Commercialization of Cancer Immunotherapy”

Dear James Love and Manon Ress:

REL0000023802.0001

Please let me know if you have any questions.

Sincerely,

Ricquita Pollard, Ph.D.
Technology Transfer Manager
Technology Transfer Center
National Cancer Institute/NIH

REL0000023802.0001

From: Wojtowicz, Emma (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=45C6610ACA6E44A08D497630425ESECD-WOJTOWICZEM]

Sent: 7/9/2019 6:12:25 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Fine, Amanda (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=61290b74aa9a44358954c45439ffdeb6-fineab]; Myles, Renate (NIH/OD) [E]
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7d317f5626934585b3692a1823c1b522-mylesr]

Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Here is the link: https://www.statnews.com/2019/07/09/dc-diagnosis-drug-prices-tv-ads/
Drug pricing advocates put NIH in the hot seat

The drug industry foe Patients For Affordable Drugs has a new report out this morning arguing that
taxpayers have contributed at least $300 million toward the development of a gene therapy to cure
sickle cell disease — and the group says that’s reason enough for the NIH to demand the treatment be
reasonably priced.

“Given the $1 to $2 million price range of recent gene therapies, we are concerned that a sickle cell
cure will be brought to market at a price that 1s unaffordable for patients and for the taxpayers who
supported its development,” the group writes. “The NIH should use all levers in its power to ensure
the final price accounts for public investment.”

The group has a number of suggestions to NIH on how to establish pricing guardrails, including
requiring that the drug maker price the drug at no more than the average of comparable OECD
nations.

This isn’t the first time drug pricing advocates have railed against NIH licensing out government-
developed drugs without restricting what drug makers can charge, but those complaints so far have
fallen on deaf ears.

An NIH spokesperson declined to comment on P4AD’s pricing concerns and emphasized that NIH
does not have a role in setting prices. The spokesperson also disputed P4AD’s argument that $300
million went to the development of this one particular therapy, because the NIH studies were
foundational research studies. “You can’t take foundational studies and apply them to one product,”
the spokesperson said.

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Sent: Tuesday, July 9, 2019 1:02 PM

To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Ce: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Did the STAT article come out?

RELO000023906

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, July 9, 2019 12:59 PM

To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

From: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Sent: Tuesday, July 9, 2019 12:55 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Hi Mark-

Did you find out if we have a patent for LentiGlobin BB305? We received another press inquiry and would like to get back
to the reporters this afternoon.

Thank you!
Emma

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Monday, July 8, 2019 3:03 PM

To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@ nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Yes, | will come up

From: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Sent: Monday, July 8, 2019 3:03 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Hi Mark-
Are you available at 3:30pm?

Thanks-
Emma

From: Wojtowicz, Emma (NIH/OD) [E]

Sent: Monday, July 8, 2019 2:01 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Ce: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

The reporter has not responded to me so we will see. Thank you-
From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Monday, July 8, 2019 10:58 AM
To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@ nih.gov>

RELO000023906

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Anytime after 1? Will that work?

From: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>
Sent: Monday, July 8, 2019 10:46 AM
To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Thanks, Mark. What is your availability?

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Monday, July 8, 2019 10:45 AM

To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: Re: From STAT: Request for comment on upcoming report on NIH research

Yes
Sent from my iPhone

On Jul 8, 2019, at 9:39 AM, Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov> wrote:
Hi Mark-

| am following up on Amanda’s email from Saturday. Let us know if you are available to speak to the
reporter before 2pm today.

Thanks-
Emma

From: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Sent: Saturday, July 6, 2019 7:01 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>

Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Thanks Mark. Do you think it would be easier if you got on the phone with him and explained it to him

on background?
I’m out Monday, but either Renate or Emma will pick this up.

Hope you have a good weekend,
Amanda

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Friday, July 5, 2019 4:31 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>

Subject: RE: From STAT: Request for comment on upcoming report on NIH research

RELO000023906

From: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Sent: Friday, July 5, 2019 4:02 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>

Subject: FW: From STAT: Request for comment on upcoming report on NIH research

Hi Mark-

RELO000023906

From: Florko, Nicholas <nicholas.florko@statnews.com>

Sent: Friday, July 5, 2019 3:10 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Ce: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Subject: Re: From STAT: Request for comment on upcoming report on NIH research

Appreciate you honoring the embargo. It's actually Patients For Affordable Drugs. And it's specifically
about the sickle cell gene therapy LentiGlobin BB305. They say taxpayer-funded NIH research has
invested more than $300 million into development of the therapy. (See table attached) Do you disagree
with this number?

And then they're calling for NIH to impose guardrails on the pricing for the drug, including:

-a commitment from a drug manufacturer — upon acquiring the NIH-supported patent — to limit the U.S.
price of a drug to no more than the average of comparable OECD nations.

-a commitment from a drug manufacturer that licensing agreements are contingent on the drug
company agreeing to price the drug based on specific metrics. (Metrics could include: Manufacturing
costs, royalty payments, clinical trials and R&D as reported to the IRS, and the value of tax credits
received in exchange for the drug’s development (i.e. orphan drug credits); Amount of money taxpayers
invested in the drug; A profit margin based on the company’s historic reported profit and loss over

a recent five-year period.)

They also suggest creating an outside advisory committee to assist NIH in developing a methodology to
determine reasonable prices.

Any chance you all could comment on whether NIH has the ability to impose such restrictions on pricing
for these drugs?

My deadline is 2PM Monday.

Thank you!

On Fri, Jul 5, 2019 at 2:36 PM Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov> wrote:
Hi Nick-

Thanks for reaching out. Is it KEI? We can honor the embargo. What are your specific questions? We
- can look into them and do our best to get back to you by your deadline.

Thanks,
_ Amanda

: Get Outlook for iOS

Sent: Friday, July 5, 2019 2:30:46 PM

RELO000023906

To: Fine, Amanda (NIH/OD) [E]; Wojtowicz, Emma (NIH/OD) [E]
Subject: Fwd: From STAT: Request for comment on upcoming report on NIH research

Hello --
Forwarding the below since Senate is out of the office! Thanks.

oo Forwarded message ---------

- From: Florko, Nicholas <nicholas.florko@statnews.com>

_ Date: Fri, Jul 5, 2019 at 2:22 PM

Subject: From STAT: Request for comment on upcoming report on NIH research
To: <mylesr@mail.nih.gov>

Hi Renate --

_ I'ma reporter over at STAT. Nice to meet you. I'm writing up an embargoed report set to go out
Tuesday from an advocacy group about NIH funding for a potential gene therapy.

- I'd like to get NIH's take on both the estimate from the authors on the level of funding taxpayers have
_ invested in the treatment, and the group's calls for there to be guardrails on the price for the drug. |
know that's vague, but | wanted to ask before | share more details: Would you be able to honor the
6AM embargo if | share more details with you?

Thanks,
Nick

_ Nick Florko

_ Washington Correspondent
: 202-549-4576

: @NicholasFlorko

_ STAT Reporting from the frontiers of health and
' medicine@stainswe | siathews.cormn | facebook.corm/statnews

for an all-access pass to exclusive stories
: the latest in health, biopharma, and science coverage.

for free newsletters with

_ Nick Florko

_ Washington Correspondent
- 202-549-4576
@NicholasFlorko

, STAT Reporting from the frontiers of health and

for an all-access pass to exclusive stories . for free newsletters with

: the latest in health, biopharma, and science coverage.

RELO000023906

Nick Florko

Washington Correspondent
202-549-4576
@NicholasFlorko

STAT : Reporting from the frontiers of health and medicine @stainews | stainews.com facebook.canvstatnews

for an all-access pass to exclusive stories.
, and science coverage.

for free newsletters with

RELO000023906

From: Niebylski, Charles (NIH/NIDDK) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=NIEBYLSKICD]

Sent: 11/2/2016 8:55:48 PM

To: Fine, Amanda (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=Fineab]; Ano, Susan (NIH/NINDS) [E]
[/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ANOS]; Rodriguez, Richard (NIH/NCI) [E]
[/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=RODRIQUR]; Rohrbaugh, Mark (NIH/OD) [E]
[/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]

cc: Chang, Kevin (NIH/NCI) [E] [/O=NIH/OU=NIHEXCHANGE/cn=RECIPIENTS/cn=CHANGKE]; Myles, Renate (NIH/OD) [E]
[/O=NIH/OU=Nihexchange/cn=recipients/cn=mylesr]; Wojtowicz, Emma (NIH/OD) [E] [/O=NIH/OU=EXCHANGE
ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=Wojtowiczeme6d]; NCI Press Officers
[/O=NIH/OU=NIHEXCHANGE/cn=NCI/cn=ncipressofficers]

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Hello,

Here is some more information on the CCZ clinical trial that Jake Liang says he is OK with sharing with the press:

The design of the CCZ trial has been posted on ClinicalTrial.Gov (NCT02118012). The preliminary analysis
did not show a significant antiviral effect, probably because of the dose we used (as allowed by the FDA).
Detailed analyses are being performed in preparation for a manuscript, which will describe the whole trial,
data analyses and outcome.

From: "Fine, Amanda (NIH/OD) [E]" <amanda.fine@nih.gov>

Date: Wednesday, November 2, 2016 at 1:08 PM

To: "Ano, Susan (NIH/NINDS) [E]" <susan.ano@nih.gov>, "Rodriguez, Richard (NIH/NCI) [E]"
<richard.rodriguez@nih.gov>, "Rohrbaugh, Mark (NIH/OD) [E]" <RohrBauM@OD.NIH.GOV>, "Niebylski, Charles
(NIH/NIDDK) [E]" <niebylskicd @@niddk.nih.gov>

Cc: Kevin Chang <changke@mail.nih.gov>, "Myles, Renate (NIH/OD) [E]" <mylesr@od.nih.gov>, "Wojtowicz, Emma
(NIH/OD) [E]" <emma.wojtowicz@nih.gov>, NCI Press Officers <ncipressofficers@mail.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi All-

Thank you again for your help on this matter. Mark spoke with Dan earlier and explained generally how and why we use
exclusive licenses,

Dan did ask for more information about the Phase 1 clinical trial of which chlorcyclizine was a part. He would like us to
confirm that it is/was a Phase 1 trial, what exactly it was for, how chlorcyclizine fit into the trial, and if there are any
results we can provide. | believe for that last question someone from this group said that results will be published soon,
however it would be good to understand if what is being published will be descriptive of the whole trial or just the
outcome of the chlorcyclizine.

Thank you for your continued guidance and input}
Amanda

From: Fine, Amanda (NIH/OD) [E]

Sent: Friday, October 28, 2016 6:11 PM

To: Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>

Cc: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>;

REL0000023966

Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI
Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski,
Charles (NIH/NIDDK) [E] <niebylskicd @niddk.nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi All-

Sorry for the delay. For your review and input, please see the below draft response:

REL0000023966

Thanks!

Amanda

On Oct 28, 2016, at 11:24 AM, Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov> wrote:

Best regards,
Sue

Susan Ano, Ph.D.

Techncolagy Development Coordinator

Office of Technology Transfer

The National institute of Neurclogical Disorders and Stroke
The National Institutes of Health

Mail address: 31 Center Drive, Sulte SA52, MS2540
Bethesda, MD 20892

Physical location: Bide. 31, 8AQ7

phone (301) 435-5515

cell: b5 i

<image0Ol jpe>

Have patience. All things are difficult before they become easy.”
~ Saadi, poet

The attachad information may be corfidential. it is intended only for the address:
the addresseels}, please note that any dissemination, distribution, or capying of t
please destray the document and notify the sender of the errar. Thank you.

{s} identified abeve. if you are not the addresseeis}, or an employes ar agent of
s communication is strictly prohibited. if you have received this email in errer,

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:12 AM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtewicz@nih.gov>; NCI
Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski,
Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>; Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>; Fine, Amanda
(NIH/OD) [E] <amanda.fine@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

REL0000023966

Richard

From: Chang, Kevin (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:08 AM

To: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Fine, Amanda (NIH/OD) [E]
<amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD)
[E] <RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E] <niebyiskicd@niddk.nih.gov>; Ano, Susan
(NIH/NINDS) [E] <susan.ano@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi Richard,

Sue was working on responses to the questions.

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only for the addressee(s) identified above. If you
are not the addressee(s), or an employee or agent of the addressee(s), please note that any dissemination,
distribution, or copying of this communication is strictly prohibited. If you have received this email in error,
please destroy the document and notify the sender of the error. Thank you.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:04 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD)

[E] <RohrBauM @OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>; Ano, Susan
(NIH/NINDS) [E] <susan.ano@nih.gov>; Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi Amanda,

REL0000023966

Just saw this and have attached my response to Chuck. If you have more questions,

I'm happy to have a call.
Thanks,

Richard

RICHARD U. RODRIGUEZ, M.Boie
Associate Director, Technology Transfer Center
Patent Agent

National Cancer Institute

National Institutes of Health

9609 Medical Center Drive, Rm 1E530

Bethesda, MD 20892-9702 (for business mail)
Rockville, MD 20850-9702 (for courier service/visitors)
Phone (Main Office): 240-276-5530

Direct phone: 240-276-6661

Fax 240-276-5504

richard.rodriqguez@nih.gov

httos://tte.nel nih.gov/index.php

“Change is inevitable. Progress is optional’ ~ Tony Roberts

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure,
copying or use of this email or the information enclosed therein is strictly prohibited, and you should notify the

sender for return of any attached documents.

From: Chang, Kevin (NIH/NCI) [E]
Sent: Thursday, October 27, 2016 6:26 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>; Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Ano,
Susan (NIH/NINDS) [E] <susan.ano@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Importance: High

Hi Amanda,
Chuck has also approached me regarding these questions. Richard, Sue, and Mark may be the best
positioned to provide NIH’s official responses on these two questions. Richard should be back from

travel on Monday but | can chat with Mark if he needs background about this specific license.

When do you need the responses to the questions by?

REL0000023966

Best regards,
Kevin

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only for the addressee(s) identified above.
if you are not the addressee(s), or an employee or agent of the addressee(s), please note that any
dissemination, distribution, or copying of this communication is strictly prohibited. If you have received
this email in error, please destroy the document and notify the sender of the error. Thank you.

From: Fine, Amanda (NIH/OD) [E]

Sent: Thursday, October 27, 2016 5:03 PM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Subject: FW: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi Kevin-

Please see the below long thread about a Buzzfeed inquiry regarding chlorcyclizine as a result of a
complaint by Knowledge Ecology International. As you may know, KEL regularly approaches NIH
regarding licensing and exercising march-in rights. We are working to set up an interview with Mark next
week, however wanted to provide the reporter with some background. He asked a few questions about
granting the license that folks said you would know and | was hoping you would help us in drafting
responses to these questions. Specifically the following 2 questions:

2} What are the institute's priorities when licensing these drugs?

(5} Some observers are asking: why grant an exclusive license to a small, unknown company with no
track record of bringing drugs to market?

Please Jet me know if you have any questions.

Thank you in advance for your help and input!
Amanda

BAP A 7 OAE

REL0000023966

Web: http:/Avww.nth. gov

NIH... Turning Discovery Into Health

From: Fine, Amanda (NIH/OD) [E]

Sent: Thursday, October 27, 2016 3:42 PM

To: Kassilke, Deborah (NIH/OD) [E] <deborah.kassilke @nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Rogers, Karen (NIH/OD) [E] <RogersK@od.nih.gov>

Cc: charies.nybeliski@nih.gov; Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd @niddk.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi Ad

Just following up on this to see if there was any progress in drafting responses to Dan's questions. His
deadline is tomorrow.

{3} How much progress has this licensee made on marketing this drug?
You would need to check with the licensee.

{4} What were the results of the Phase J trial that NIH funded on this drug?

REL0000023966

These will be published in the near future.

(5) Some observers are asking: why grant an exclusive license to a small, unknown company with no
track record of bringing drugs to market?

Chuck-were you able to speak to Kevin Chang about this?
Thanks to all in advance for your input and guidance.

Best,
Amanda

From: Kassilke, Deborah (NIH/OD) [E]
Sent: Tuesday, October 25, 2016 11:34 AM
To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Rogers, Karen (NIH/OD) [E]

<RogersK@od.nih.gov>
Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; charles.nybeliski@nih.gov; Niebylski, Charles

(NIH/NIDDK) [E] <niebylskicd @niddk.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News
Morning Mark —

You had a bad address for Chuck so I’m adding him in with his NIDDK email.

This is actually for NIDDK to respond as we (OTT) would not feel comfortable answering questions for
NIDDK on their licenses. That said, we will certainly assist NIDDK with the information we can find.

Chuck, let’s chat on this tomorrow.
Deb

REL0000023966

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, October 25, 2016 10:15 AM

To: Kassilke, Deborah (NIH/OD) [E] <deborah.kassilke@nih.gov>; Rogers, Karen (NIH/OD) [E]
<RogersK @od.nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; charles.nybeliski@nih.gov

Subject: Fwd: Interview request/chlorcyclizine pricing: BuzzFeed News

Deb and Karen:

Could you please help me follow up on this for Amanda and the press inquiry? BB
Thanks
Mark

Sent from my iPhone
Begin forwarded message:

From: "Rohrbaugh, Mark (NIH/OD) [E]" <RohrBauM@OD.NIH.GOV>
Date: October 24, 2016 at 9:49:59 PM GMT+1

Ce: "Fine, Amanda (NIH/OD) [E]" <amanda.fine@nih.gov>
Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Chuck:

See thread below. Could you help answer the questions about NIH
licensing?

Thanks
Mark

Sent from my iPhone

Begin forwarded message:

From: "Portilla, Lili (NIH/NCATS) [E]"
<portilll@mail.nih.gov>

Date: October 24, 2016 at 9:22:01 PM GMT+1
To: "Rohrbaugh, Mark (NIH/OD) [E]"
<RohrBauM@OD.NIH.GOV>, "Vepa, Sury
(NIH/NCATS) [E]" <sury.vepa@nih.gov>
Subject: RE: Interview request/chlorcyclizine
pricing: BuzzFeed News

Mark:

REL0000023966

NIDDK tock the lead on this as their P] Uake Liang} was
the biology lead. NCATS has a few co-inventors on the
patent who did screening and med chem. The licensing
for this was done by OTT specifically Kevin

Chang. Chuck Nybeliski was also very involved on the
NCATS side when he was part of our office. [would
speak to him on this matter in his role as Director of the
NIDDK TTO,

Regards,

Lil

LEM, Portilla, MPA

Director, Office of Strategic Alliances

National Center for Advancing Translational Sciences,
NIH

9800 Medical Center Drive, Room 3042

Rockville, MD 20850

Phone: 301-217-2589

Email: Lilip@nih.gov

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, October 24, 2016 3:51 PM

To: Driscoll, Claire (NIH/NHGRI) [E]
<cdriscol@mail.nih.gov>; Vepa, Sury (NIH/NCATS) [E]
<sury.vepa@nih.gov>; Portilla, Lili (NIH/NCATS) [E]
<portilll@mail.nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing:
BuzzFeed News

Sorry Claire, meant to copy Lili
Sent from my iPhone
On Oct 24, 2016, at 8:50 PM, Rohrbaugh, Mark

(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>
wrote:

Sent from my iPhone

REL0000023966

Begin forwarded message:

From: "Fine,
Amanda (NIH/OD)
[E]"
<amanda.fine@nih.go
v>

Date: October 24,
2016 at 8:27:59 PM
GMT+1

To: "Rohrbaugh,
Mark (NIH/OD) [E]"

<RohrBauM@OD.NI

Ce: "McBurney,
Margaret (NIH/OD)
[E]"
<mmeburney@od.nih
.gov>, "Hardesty,
Rebecca (NIH/OD)
[C]"
<rebecca.hardesty@ni
h.gov>, "Myles,
Renate (NIH/OD)
[E]"
<mylesr@od.nih.gov
>, "Wojtowicz, Emma
(NIH/OD) [E]"
<emma,.wojtowicz@n
ih.gov>

Subject: RE:
Interview
request/chlorcyclizin
e pricing: BuzzFeed
News

REL0000023966

Thanks Mark! Hope
you're not working
while on vacation.

Amanda

From: Rohrbaugh, Mark
(NIH/OD) [E]

Sent: Monday, October
24, 2016 3:22 PM

To: Fine, Amanda
(NIH/OD) [E]
<amanda.fine@nih.gov
>

Cc: McBurney,
Margaret (NIH/OD) [E]
<mmcburney @od.nih.g
ov>; Hardesty, Rebecca
(NIH/OD) [C]
<rebecca.hardesty@nih
.Zov>; Myles, Renate
(NIH/OD) [E]
<mylesr@od.nih.gov>;
Wojtowicz, Emma
(NIH/OD) [E]
<emma.wojtowicz@nih
.ZOv>

Subject: Re: Interview
request/chlorcyclizine
pricing: BuzzFeed News

lam available. Looks
ok to me. Not sure
why the email thread

REL0000023966

was released under

FOIA. There is more
one could say but this
is the basic

message. b5 ;

Pormeaneateinatastske — Aeetaeeeer! a

Sent from my iPhone

On Oct 24, 2016, at
8:10 PM, Fine,
Amanda (NIH/OD)
[E]
<amanda.fine@nih.go
v> wrote:

Greetin

g5-

len
includin
gall
three of
you per
Mark's
out of
office
and
given
that the
reporte
rs
deadlin
eis
Octobe
r 28.

NIDDK
receive
d the
below
inquiry
fram
Dan
Vergan
oat
Buzzfee

REL0000023966

d
regardi
ng
Knowle
dge
Ecology
interna
tlonal’s
(KE})
questio
ns
about
the
drug
chlorcy
clizine
which
had/ha
$a
small
trial at
the CC.
Attache
disa
back
and
forth
with
NIDDE/
NCATS
that KEI
got
through
FOIA.
Dan's
questio
ns are

REL0000023966

REL0000023966

REL0000023966

Thank

you in

advanc
e for

your

input

and

©

guidanc
é,

Amand
-

manda. fi
ne(@nib.

REL0000023966

Webhtt

p//Awww

nih.gov

NIH...
Turning
Discove
ry Into
Health

From:
Payne,
January
(NIH/NI
DDK)

Octobe
r 24,
2016
2:54

REL0000023966

@niddk

«nih.gov
>

Subject

Intervie
Ww
request
/chlorc
yclizine
pricing:
BuzzFe
ed
News

Hello,
NIDDK
receive
dan
intervie
w
request
from a
Buzzfe
ed
reporter
asking
about
NIH
involve
ment in
licensin
g and
drug
pricing
for
chlorcy
clizine.
Chuck
Niebyls
ki,
director

NIDDK’
s
Technol
ogy
Advanc
ement
Office,
asked
that |
refer
this
request
to NIH
OD as
it
involve
s NIH’s

REL0000023966

policy
on drug
pricing.

Below
is the
complet
e email
exchan
ge I’ve
had
with the
reporter
, Dan
Vergan
o, and
attache
disa
PDF of
an
email
chain
betwee
n NIH
employ
ees that
the
reporter
receive
dviaa
public
interest
group
called
Knowle
dge
Ecology
internat
ional,
which
obtaine
d the
records
viaa
FOIA
request

(Please
note,
for
backgro
und:
KEl
also
publish
ed this
2015
post
about
the
same
drug.)

REL0000023966

Is NIH
OD
able to
respon
d to this

request
?

Thank
you,
January
Ww.
Payne
Office
of
Commu
nication
s and
Public
Liaison
Nationa
|
Institute
of
Diabete

REL0000023966

Health
®

Cslebra

Watch
how
medical
researc
h saves
lives
and
improv
es

health

From:
Dan
Vergan
fe)
[mailto:
dan.ver
ano
buzzfee

Octobe
r 24,
2016
12:29
PM

To:
Payne,
January
(NIH/NI
DDK)
{E]
<januar
y.payne
@nih.g
ov>
Subject
: Re:
BuzzFe
ed
News:
press

REL0000023966

contact

/

licensin
g

Januar
y,

Thanks
for
getting
back to
me

-- The
drug is
chlorcy
clizine
(link to
license
annc't
below)
, and
the publ
ic
interest
group,
Knowled
ge
Ecology
Internati
onal
(which
often
looks at
NIH
licenses)
1s
complain
ing that
its
request
for
"reasona
ble
pricing”
requirem
ents in
the
license
were
brushed
aside to
the
detrimen
tof
taxpayer
s. The
group

REL0000023966

has just
received
a public
records
request
(a
portion
is
attached)
and
suggests
they
show
that NIH
is
worried
more
about
scaring
off the
licensee
than
benefitin
g the
taxpayer
s who
funded
this drug
and have
no
assurance
e they
won't
have to
PAY on:
eXcessiv
ely high
prices
for it.

-- I'm
looking
for an
agency
response
to this
contentio
n.

— My
deadline
is
10/28/16
at 5 PM
EDT

ee My
questions
would
basically
be:

How do
you.
respond
to their

REL0000023966

complain

institute!
$
priorities
when
licensing
these
drugs?
How
much

progress
has this
licensee
made on
marketin
g this
drug?
What
were the
results of
the

Phase 1
trial that
NIH
funded
on this

drug?
Some
observ
ers are
asking:
why
grant
an
exclusi
ve
license
toa
small,
unkno
wn
compa
ny
with
no
track
record
of
bringin
g drugs
to

market
a

REL0000023966

I'd
have
follow-
ups
depend
ing on
the
answer
S,
natch,
and
would
want to
hear
any
respon
ses to
smarter
questio
ns on
all this
that
your
folks
might
have.

Any help
appreciat
ed,

Dan
Vergano
BuzzFee
d News
202 629
4563

Science
Reporte

REL0000023966

On
Mon,
Oct 24,
2016 at
11:57
AM,
Payne,
Januar

bf

(NIH/
NIDD
K) [E]

<janua
ry.pay

REL0000023966

ne(@ni

h.gov>
wrote:

Dear
Dan,

Thank
s for
your
messa
ge.
Can
you
please
provid
e
more
inform
ation
so |
can
look
into
your

reques
t?

you
please
briefly
descri
be the
issue
that
has
been
raised
? Also,
what
is the
name
of the
public

REL0000023966

interes
t

group
?

Ww
hat is
your
hard
deadli
ne?

Ca
n you
please
provid
ea
few
examp
les of
questi
ons
you'd
like to
ask?

Comm
unicati
ons
and
Public
Liaiso
n
Nation
al
Institut
e of
Diabet
es
andDi
gestiv
e and
Kidney
Diseas
es

REL0000023966

Discov
ery
into
Health
®

resear
ch
Saves
lives
and
impro
ves
health

From:
Dan
Verga
no
[mailt
o:dan.

REL0000023966

vergan
o@bu
zzfeed
com]
Sent:
Mond
ay,
Octob
er 24,
2016
11:25
AM
To:
NIDDK
NIDDK
MEDIA
(NIH/
NIDDK
)
<niddk
media
@nidd
ov>
Subjec
t: Fwd:
BuzzFe
ed
News:
press
contac
t/
licensi
ng

REL0000023966

phone
messa
ge
with
the
press
office.
lam
lookin
g for
comm
ent
this
week.

Ms.
Carrer
a,

I'ma
scienc
€
report
er at
Buzz
Feed
News.
I'm
lookin
g for
a
press
conta
ct at
NIDD
K
who
can
addre
ss a
drug
licens
ing
issue
at
your
institu
te. A
public
intere

REL0000023966

st
group
is
raisin
& .
questi
ons
about
one of
your
licens
es and
I'd
like to
geta
respo
nse
from
the
institu
te.

Thank
s for
any
help,

Dan
Verga
no

Buzz
Feed
News

202/6
29-
4563

Dan
Verga
no |
Scienc

REL0000023966

e
Report
er
(DC) |
202
629
4563
BuzzF
eed
1630
Conne
cticut
Ave.
7th
Floor,
Washi
ngton
DC
20009

JANUARY PAYNE

@ National Institutes of Health

National Institutes of Health | 9000 Rockville Pike, Bethesda, MD 20892, USA | Official
(NIH). NIH is one of the world's foremost medical research centers. An agency of...

January Payne on Linkedin

, ee
=| @NIH | 663K followers | 6K tweets - °

There's still time to submit your 22 NiH_i.RP application! Get started on yours today.
biLiv/se? GDztestudentuebt

| = Search for January Payne on Google

REL0000023966

<Reas

onable
Pricing
Virotas
NIH
.pdf>
<image001 jpg>
<image001 .jpg>
<image001 jpg>
<image001 .jpg>

REL0000023966

From: Wojtowicz, Emma (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=45C6610ACA6E44A08D497630425ESECD-WOJTOWICZEM]
Sent: 7/8/2019 7:03:39 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
cc: Fine, Amanda (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=61290b74aa9a44358954c45439ffdeb6-fineab]; Myles, Renate (NIH/OD) [E]
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=7d317f5626934585b3692a1823c1b522-mylesr]

Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Okay, thank you.

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Sent: Monday, July 8, 2019 3:03 PM

To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Yes, | will come up

From: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Sent: Monday, July 8, 2019 3:03 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Hi Mark-
Are you available at 3:30pm?

Thanks-
Emma

From: Wojtowicz, Emma (NIH/OD) [E]

Sent: Monday, July 8, 2019 2:01 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

The reporter has not responded to me so we will see. Thank you-

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>
Sent: Monday, July 8, 2019 10:58 AM
To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Anytime after 1? Will that work?

From: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>
Sent: Monday, July 8, 2019 10:46 AM

REL0000023987

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>
Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Thanks, Mark. What is your availability?

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Monday, July 8, 2019 10:45 AM

To: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>
Subject: Re: From STAT: Request for comment on upcoming report on NIH research

Yes
Sent from my iPhone

On Jul 8, 2019, at 9:39 AM, Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov> wrote:
Hi Mark-

| am following up on Amanda’s email from Saturday. Let us know if you are available to speak to the
reporter before 2pm today.

Thanks-
Emma

From: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Sent: Saturday, July 6, 2019 7:01 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>

Subject: RE: From STAT: Request for comment on upcoming report on NIH research

Thanks Mark. Do you think it would be easier if you got on the phone with him and explained it to him

on background?
I’m out Monday, but either Renate or Emma will pick this up.

Hope you have a good weekend,
Amanda

From: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum@od.nih.gov>

Sent: Friday, July 5, 2019 4:31 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>

Subject: RE: From STAT: Request for comment on upcoming report on NIH research

REL0000023987

From: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Sent: Friday, July 5, 2019 4:02 PM

To: Rohrbaugh, Mark (NIH/OD) [E] <rohrbaum @od.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@mail.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>

Subject: FW: From STAT: Request for comment on upcoming report on NIH research

Hi Mark-

REL0000023987

From: Florko, Nicholas <nicholas.florko@statnews.com>

Sent: Friday, July 5, 2019 3:10 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Ce: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@ nih.gov>

Subject: Re: From STAT: Request for comment on upcoming report on NIH research

Appreciate you honoring the embargo. It's actually Patients For Affordable Drugs. And it's specifically
about the sickle cell gene therapy LentiGlobin BB305. They say taxpayer-funded NIH research has
invested more than $300 million into development of the therapy. (See table attached) Do you disagree
with this number?

And then they're calling for NIH to impose guardrails on the pricing for the drug, including:
-acommitment from a drug manufacturer — upon acquiring the NIH-supported patent — to limit the U.S.
price of a drug to no more than the average of comparable OECD nations.

-a commitment from a drug manufacturer that licensing agreements are contingent on the drug
company agreeing to price the drug based on specific metrics. (Metrics could include: Manufacturing
costs, royalty payments, clinical trials and R&D as reported to the IRS, and the value of tax credits
received in exchange for the drug’s development (i.e. orphan drug credits); Amount of money taxpayers
invested in the drug; A profit margin based on the company’s historic reported profit and loss over

a recent five-year period.)

They also suggest creating an outside advisory committee to assist NIH in developing a methodology to
determine reasonable prices.

Any chance you all could comment on whether NIH has the ability to impose such restrictions on pricing
for these drugs?

My deadline is 2PM Monday.

Thank you!

On Fri, Jul 5, 2019 at 2:36 PM Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov> wrote:
Hi Nick-

Thanks for reaching out. Is it KEI? We can honor the embargo. What are your specific questions? We
» can look into them and do our best to get back to you by your deadline.

Thanks,
» Amanda

Get Outlook for iOS

From: Florko, Nicholas <nicholas.florko@statnews.com>

Sent: Friday, July 5, 2019 2:30:46 PM

- To: Fine, Amanda (NIH/OD) [E]; Wojtowicz, Emma (NIH/OD) [E]

Subject: Fwd: From STAT: Request for comment on upcoming report on NIH research

Hello --

Forwarding the below since Senate is out of the office! Thanks.

REL0000023987

woceescce= Forwarded message ---------

_ From: Florko, Nicholas <nicholas.florko@statnews.com>

_ Date: Fri, Jul 5, 2019 at 2:22 PM

Subject: From STAT: Request for comment on upcoming report on NIH research
— To: <mylesr@mail.nih.gov>

Hi Renate --

_ I'ma reporter over at STAT. Nice to meet you. I'm writing up an embargoed report set to go out
Tuesday from an advocacy group about NIH funding for a potential gene therapy.

_ I'd like to get NIH's take on both the estimate from the authors on the level of funding taxpayers have
invested in the treatment, and the group's calls for there to be guardrails on the price for the drug. |
know that's vague, but | wanted to ask before | share more details: Would you be able to honor the
6AM embargo if | share more details with you?

Thanks,
» Nick

Nick Florko

_ Washington Correspondent
202-549-4576

_ @NicholasFlorko

STAT | Reporting from the frontiers of health and

for free newsletters with

for an all-access pass to exclusive stories
: the latest in health, biopharma, and science coverage.

Nick Florko

: Washington Correspondent
- 202-549-4576

: @NicholasFlorko

- STAT Reporting from the frontiers of health and
medicine@stainews | statnews.corm | facebook.com/statnews

for an all-access pass to exclusive stories
iopharma, and science coverage.

for free newsletters with

Nick Florko

Washington Correspondent
202-549-4576
@NicholasFlorko

REL0000023987

STAT : Reporting from the frontiers of health and medicine@stainews | siainews.com facebook.com/statnews

for free newsletters with

for an all-access pass to exclusive stories
iopharma, and science coverage.

the latest in healt

REL0000023987

From: Pollard, Ricquita (NIH/NCI) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=DC946982E43F43CB925773EA52C40AFA-POLLARDRD]

Sent: 8/21/2018 5:03:12 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Chatterjee, Sabarni (NIH/NCI) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=f4520fc058d6457aac24b57685235b12-chatterjees]

Subject: FW: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development and

Commercialization of Cancer Immunotherapy, per 83 FR 35665
Attachments: Response to KEl_comments on A-311-2018.docx; 2018-16058 FRN_A-311-2018.pdf

Hi Mark,

| am processing a Start-Up Exclusive License application (A-311-2018) from Midissia Therapeutics for a cancer
immunotherapy. The Federal Register Notice for this application (attached) was posted on July 27" and the comment
period according to the notice ended August 13°". | received an email from James Love and Manon Ress on August
13" (see below) with comments from Knowledge Ecology International (KEI) and the Union for Affordable Cancer
Treatment (UACT) addressing four topics: 1) No discrimination against US residents in pricing, 2) Reduce term of
exclusivity when revenues are large, 3) Developing countries, and 4) Transparency.

Please see my proposed response in the attached WORD document. If you have any questions or concerns, please let
me know.

Thanks,
Ricquita

Ricquita D. Pollard, Ph.D.

Technology Transfer Manager

Technology Transfer Center

National Cancer Institute

9609 Medical Center Drive, Rm 1-E530
Bethesda, MD 20892-9702 (for business mail)
Rockville, MD 20850-9702 (for courier service/visitors)
Phone (Main Office): (240) 276-5530

Direct Phone: (240) 276-5490

Fax: (240) 276-5503

pollardrd@mail nih gov

Note: This email may contain confidential information. If you are not the intended recipient, any disclosure, copying or
use of this email or the information enclosed therein is strictly prohibited, and you should notify the sender for return of
any attached documents.

From: James Love <james.love@keionline.org>

Sent: Monday, August 13, 2018 11:48 PM

To: Pollard, Ricquita (NIH/NCI) [E] <ricquita.pollard@nih.gov>

Subject: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development and
Commercialization of Cancer Immunotherapy, per 83 FR 35665

August 13, 2018

REL0000024009

Ricquita Pollard, Technology Transfer Manager,
NCI Technology Transfer Center,

Via Email: pollardrd@mail.nih.gov.

Re: Prospective Grant of an Exclusive Patent License to Midissia Therapeutics for the Development
and Commercialization of Cancer Immunotherapy, per 83 FR 35665

Dear Ricquita Pollard:

The following are comments from Knowledge Ecology International (KE!) and the Union for Affordable
Cancer Treatment (UACT), on the proposed exclusive license for patents noticed in the Federal
Register for a license to Midissia Therapeutics (“Midissia”) located in San Francisco, California.

1. No discrimination against US residents in pricing

We ask that the NIH include language in the proposed exclusive license to ensure that the prices in
the U.S. for any drug, vaccine, medical device or other health technology using the inventions are not
higher than the median price charged in the seven countries with the largest gross domestic product
(GDP), that also have a per capita income of at least 50 percent of the United States, as measured by
the World Bank Atlas Method.

We consider this a modest request to protect U.S. residents, who paid for the R&D that created the
licensed inventions.

2. Reduce term of exclusivity when revenues are large

In addition to an external reference pricing test, we propose that the exclusivity of the license in the
U.S. should be reduced when the global cumulative sales from products or services using the
inventions exceed certain benchmarks.

Given the modest cost of acquiring an NIH patented invention, the amount of money the developer
needs in sales to justify additional investments in R&D is reduced, as compared to cases where a
company developes or acquires the technology from non government sources.

This request is consistent with the statutory requirements of 35 USC 209, which requires that “the
proposed scope of exclusivity is not greater than reasonably necessary to provide the incentive for
bringing the invention to practical application.”

One possible implementation of revenue benchmarks is as follows: exclusivity will be reduced by one
year for every $500 million in revenue equivalents, earned after the first $1 billion, where revenue
equivalent is defined as global cumulative sales plus market entry rewards as well as government
grants or tax credits, for the product or products using the invention. However, the NIH could choose
different benchmarks, so long as the limits on exclusivity address the requirements of 35 USC 209,
that the incentive is “not greater than reasonably necessary.”

3. Developing countries
We are concerned that several NIH funded inventions are not accessible in developing countries, due

to prices that are high and not affordable in markets where per capita incomes are significantly lower
than the United States. For this reason, we ask the NIH to limit the exclusivity in the license to

countries that have per capita incomes that are at least 30 percent of the United States.

REL0000024009

We also ask the NIH to reach out to the Medicines Patent Pool (MPP), in order to enter into an
agreement that gives the MPP an option to negotiate non-exclusive open licenses for the inventions
in developing countries.

4. Transparency

The licensee should be required to file an annual report to the NIH, available to the public, on the
research and development (R&D) costs associated with the development of any product that uses the
inventions, including reporting separately and individually the outlays on each clinical trial. We will
note that this is not a request to see a company business plan or license application. We are asking
that going forward the company be required to report on actual R&D outlays to develop the subject
inventions. Reporting on actual R&D outlays is important for determining if the NIH is meeting the
requirements of 35 USC 209, that “the proposed scope of exclusivity is not greater than reasonably
necessary to provide the incentive for bringing the invention to practical application.” Specifically,
having data on actual R&D outlays on each clinical trial used to obtain FDA approval provides
evidence that is highly relevant to estimating the risk adjusted costs of bringing NIH licensed
inventions to market.

Sincerely,

James Love
Knowledge Ecology International

Manon Anne Ress
Union for Affordable Cancer Treatment

James Love. Knowledge Ecology International
http://www.keionline.org/donate. html]
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile: +41.76.413.6584, twitter.com/jamie love

REL0000024009

August 20, 2018

James Love
Scientific and Technical Advisor
Knowledge Ecology International

Manon Anne Ress

Union for Affordable Cancer Treatment

IN RE: Your Letter Dated August 13, 2018 in response to 83 FR 35663, Published July 27, 2018
“Prospective Grant of Exclusive Patent License to Midissia Therapeutics for the Development and
Commercialization of Cancer Immunotherapy”

Dear James Love and Manon Ress:

Please let me know if you have any questions.

Sincerely,

Ricquita Pollard, Ph.D.
Technology Transfer Manager
Technology Transfer Center
National Cancer Institute/NIH

REL0000024009.0001

AUTHENTICATED
US. GOVERNMENT,
INFORMATION

USPS,

Federal Register/Vol. 83, No. 145/Friday, July 27, 2018/ Notices

35665

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

Prospective Grant of an Exclusive
Patent License: Development and
Commercialization of Cancer
Immunotherapy

AGENCY: National Institutes of Health,
Department of Health and Human
Services.

ACTION: Notice.

SUMMARY: The National Cancer Institute,
an institute of the National Institutes of
Health, Department of Health and
Human Services, is contemplating the
grant of an Exclusive Patent License to
practice the inventions embodied in the
U.S. Patents and Patent Applications
listed in the Supplementary Information
section of this notice to Midissia
Therapeutics (“‘Midissia’’) located in
San Francisco, CA.

DATES: Only written comments and/or
applications for a license which are
received by the National Cancer
Institute’s Technology Transfer Center
on or before August 13, 2018 will be
considered.

ADDRESSES: Requests for copies of the
patent application, inquiries, and
comments relating to the contemplated
Exclusive Patent License should be
directed to: Ricquita Pollard,
Technology Transfer Manager, NCI
Technology Transfer Center, 9609
Medical Center Drive, RM 1E530 MSC
9702, Bethesda, MD 20892-9702 (for
business mail), Rockville, MD 20850-
9702; Telephone: (240) 276-5530;
Facsimile: (240) 276-5504; Email:
pollardrd@mail.nih.gov.
SUPPLEMENTARY INFORMATION:

Intellectual Property

1. United States Provisional Patent
Application No. 62/248,964 filed Oct. 30,
2015 for “Compositions and Methods for
the Treatment of HER2-Expressing Solid
Tumor “[HHS Ref. No. E-187—2015/
OUS-01];

2. International Patent Application No. PCT/
US2016/059680 filed October 31, 2016
for “Compositions and Methods for
Treatment of HER2-Expressing Solid
Tumor’’ [HHS Reference No. E-187—
2015/0—PCT-02];

3. Canadian National Stage Patent
Application (No. not yet assigned), filed
April 30, 2018 [HHS Ref. No. E-187—
2015/0-CA-03];

4, Japanese National Stage Patent Application
No. 2018-521518, filed April 30, 2018
[HHS Ref. No. E~187—2015/0—JP-04];

5. Australian National Stage Patent
Application No. 2016343845, filed April
30, 2018 [HHS Ref. No. E-187—2015/0—
AU-O5];

6. European National Stage Patent
Application. (No. not yet assigned), filed
April 30, 2018 [HHS Ref. No. E-187—
2015/0-EP—06];

7. U.S. National Stage Patent Application No.
15/771,932, filed April 30, 2018 [HHS
Ref. No. E-187—2015/0-US-07];

The patent rights in these inventions
have been assigned and/or exclusively
licensed to the government of the
United States of America.

The prospective exclusive license
territory may be worldwide and the
field of use may be limited to
“development and commercialization of
Ad-HER2 vaccines as a therapeutic
against HER2-positive cancers as
covered within the scope of the
Licensed Patent Rights, excluding uses
in combination with vectors/adjuvants,
checkpoint inhibitors or other immune
modulators.”

This technology describes a
recombinant adenoviral vector that
expresses the extracellular (EC) and
transmembrane (TM) domains of the
human HER2 protein and is designed to
induce a polyclonal anti-tumor
response. HER2 is a member of the
epidermal growth factor family and is
overexpressed in subsets of breast,
ovarian, gastric, colorectal, pancreatic
and endometrial cancers. This vaccine
encodes for the entire EC and TM
domains of human HER2neu and is
specifically contained within a
recombinant adenoviral vector that has
the knob of Adenovirus 5 and
substituted fiber of Adenovirus 35. The
substitution of the knob of Adenovirus
35 whose receptor is CD46 allows for
efficient and maximal transduction of
human dendritic and hematopoietic
cells.

This notice is made in accordance
with 35 U.S.C. 209 and 37 CFR part 404.
The prospective exclusive license will
be royalty bearing, and the prospective
exclusive license may be granted unless
within fifteen (15) days from the date of
this published notice, the National
Cancer Institute receives written
evidence and argument that establishes
that the grant of the license would not
be consistent with the requirements of
35 U.S.C. 209 and 37 CFR part 404.

In response to this Notice, the public
may file comments or objections.
Comments and objections, other than
those in the form of a license
application, will not be treated
confidentially, and may be made
publicly available.

License applications submitted in
response to this Notice will be
presumed to contain business
confidential information and any release
of information in these license
applications will be made only as

required and upon a request under the
Freedom of Information Act, 5 U.S.C.
552,

Dated: July 19, 2018.
Richard U. Rodriguez,
Associate Director, Technology Transfer
Center, National Cancer Institute.
{FR Doc. 2018-16058 Filed 7-26-18; 8:45 am]

BILLING CODE 4140-01-P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

National Institutes of Health

Proposed Collection; 60-Day Comment
Request; Intramural Continuing
Umbrella of Research Experiences
(iCURE) Application (National Cancer
Institute)

AGENCY: National Institutes of Health,
Department of Health and Human
Services.

ACTION: Notice.

SUMMARY: In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Cancer Institute (NCD will
publish periodic summaries of propose
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.

DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.

FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Alison Lin, 9609 Medical
Center Drive, Rockville, MD 20850 or
call non-toll-free number (240) 276—
6177 or Email your request, including
your address to: linaj@mail.nih.gov.
Formal requests for additional plans and
instruments must be requested in
writing.

SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: Written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the

RELO0000024009.0002

From: Surabian, Karen (NIH/NIAID) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=604A0E2013504631921434A90B327010-SURABIANK_1]
Sent: 6/29/2018 3:44:09 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]
cc: Williams, Richard (NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=e5f89fe4d2 7a43abb936bb20efeca3b9-rwilliams]; Mowatt, Michael
(NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=cb1lef7e2e54b4164ae34814574bda638-mmowatt]; Frisbie, Suzanne
(NIH/NIAID) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=c402740ceaad4d4f97a8c28f16fbb349-frisbies]; Kirby, Tara (NIH/NIAID) [E]
[/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=2368a591fa4c4932a802e5d467fb49ed-tarak]; Puglielli, Maryann (NIH/NIAID)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=9f53ceacaf754875a948081bac5cc66a-pugliellim]; Sayyid, Fatima (NIH/NIAID)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=5b9e4504 1bdb43719f7113aS5aae27057-sayyidf]; Soukas, Peter (NIH/NIAID)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=b1f6020157ac47948c6e34166b78e433-soukasp]

Subject: Draft Email in response to FRN for review

Attachments: Draft Email Response 062818.docx

Hello Mark,

Thank you for discussing this with us on Wednesday. Please see the attached for your review.
Please let me know if OGC (Dale) would want to see this as well.

lam available Monday if you want to further discuss.

Thank you again.

Sincerely,

Karen

Karen T. Surabian

Licensing and Patenting Manager

CDC Team

Technology Transfer and Intellectual Property Office (TTIPO)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health (NIH)

5601 Fishers Lane, Rm. 2G48, MSC 9804

Rockville, MD 20892

Phone: 301-594-9719
Email: karen.surabian@nih.gov

The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should
not be used by anyone who is not the original intended recipient. If you have received this e-mail in error please inform
the sender and delete it from your mailbox or any other storage devices. National Institute of Allergy and Infectious

REL0000024011

Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of
NIAID by one of its representatives.

RELO000024011

Dear Mr. Love,

REL0000024011.0001

iia va ces ipa mre cay ic a st nts eats tee tc ae etm daca acta eet eaten Poe es inet See eee eee een Pais rie genera ces ines tater enema imme teg

From: Fine, Amanda (NIH/OD) [E] [/O=EXCHANGELABS/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=61290B74AA9A44358954C45439FFDEB6-FINEAB]

Sent: 7/5/2019 8:01:31 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=591ab6b2424b4b8997082718cbb29fab-rohrbaum]

cc: Myles, Renate (NIH/OD) [E] [/o=ExchangeLabs/ou=Exchange Administrative Group

(FYDIBOHF23SPDLT)/cn=Recipients/cn=7d317f5626934585b3692a1823c1b522-mylesr]; Wojtowicz, Emma (NIH/OD)
[E] [/o=ExchangeLabs/ou=Exchange Administrative Group
(FYDIBOHF23SPDLT)/cn=Recipients/cn=45c6610aca6e44a08d497630425e5ecd-wojtowiczem]

Subject: FW: From STAT: Request for comment on upcoming report on NIH research

Attachments: Screen Shot 2019-07-05 at 3.08.38 PM.png

Hi Mark-

Please see below/attached.| b5

iin hr rt ert a ht err he rere rrr ae

Amanda

From: Florko, Nicholas <nicholas.florko@statnews.com>

Sent: Friday, July 5, 2019 3:10 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Wojtewicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>

Subject: Re: From STAT: Request for comment on upcoming report on NIH research

REL0000024037

Appreciate you honoring the embargo. It's actually Patients For Affordable Drugs. And it's specifically about the sickle
cell gene therapy LentiGlobin BB305. They say taxpayer-funded NIH research has invested more than $300 million into
development of the therapy. (See table attached) Do you disagree with this number?

And then they're calling for NIH to impose guardrails on the pricing for the drug, including:

-a commitment from a drug manufacturer — upon acquiring the NIH-supported patent — to limit the U.S. price of a drug
to no more than the average of comparable OECD nations.

-a commitment from a drug manufacturer that licensing agreements are contingent on the drug company agreeing to
price the drug based on specific metrics. (Metrics could include: Manufacturing costs, royalty payments, clinical trials
and R&D as reported to the IRS, and the value of tax credits received in exchange for the drug’s development (i.e.
orphan drug credits); Amount of money taxpayers invested in the drug; A profit margin based on the company’s historic
reported profit and loss over a recent five-year period.)

They also suggest creating an outside advisory committee to assist NIH in developing a methodology to determine
reasonable prices.

Any chance you all could comment on whether NIH has the ability to impose such restrictions on pricing for these drugs?

My deadline is 2PM Monday.

Thank you!

On Fri, Jul5, 2019 at 2:36 PM Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov> wrote:
Hi Nick-

Thanks for reaching out. Is it KEI? We can honor the embargo. What are your specific questions? We can look into them
and do our best to get back to you by your deadline.

| Thanks,
_ Amanda

: Get Outlook for iOS

- Sent: Friday, July 5, 2019 2:30:46 PM
To: Fine, Amanda (NIH/OD) [E]; Wojtowicz, Emma (NIH/OD) [E]
» Subject: Fwd: From STAT: Request for comment on upcoming report on NIH research

Hello --

Forwarding the below since Senate is out of the office! Thanks.
: noneceenee Forwarded message ---------

| From: Florko, Nicholas <nicholas.florko@statnews.com>

- Date: Fri, Jul5, 2019 at 2:22 PM

Subject: From STAT: Request for comment on upcoming report on NIH research
_ To: <mylesr@mail.nih.gov>

Hi Renate --

REL0000024037

_ I'ma reporter over at STAT. Nice to meet you. I'm writing up an embargoed report set to go out Tuesday from an
» advocacy group about NIH funding for a potential gene therapy.

_ I'd like to get NIH's take on both the estimate from the authors on the level of funding taxpayers have invested in the
treatment, and the group's calls for there to be guardrails on the price for the drug. | know that's vague, but | wanted
to ask before | share more details: Would you be able to honor the 6AM embargo if | share more details with you?

i Thanks,
Nick

- Nick Florko

_ Washington Correspondent

- 202-549-4576
@NicholasFlorko

STAT | Reporting from the frontiers of health and medicine @s'

for an all-access pass to exclusive stories. : for free newsletters with the latest in health,

age.

_ Nick Florko

_ Washington Correspondent
202-549-4576
@NicholasFlorko

a

STAT Reporting from the frontiers of health and medicine@stainews | statnews.corn | facehoak.com/statnews

for an all-access pass to exclusive stories. : for free newsletters with the latest in health,

lopnarma, ana science coverage.

Nick Florko

Washington Correspondent
202-549-4576
@NicholasFlorko

= for an all-access pass to exclusive stories = for free newsletters with the latest in health,

biopharma, and science coverage.

REL0000024037

RELO0000024037.0001

From: Fine, Amanda (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=FINEAB]

Sent: 10/31/2016 2:58:37 PM

To: Rohrbaugh, Mark (NIH/OD) [E] [/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ROHRBAUM]; Myles, Renate (NIH/OD) [E]
[/O=NIH/OU=Nihexchange/cn=recipients/cn=mylesr]; Chang, Kevin (NIH/NCI) [E]
[/O=NIH/OU=NIHEXCHANGE/cn=RECIPIENTS/cn=CHANGKE]; Ano, Susan (NIH/NINDS) [E]
[/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=ANOS]; Rodriguez, Richard (NIH/NCI) [E]
[/O=NIH/OU=NIHEXCHANGE/cn=OD/cn=RODRIQUR]; Niebylski, Charles (NIH/NIDDK) [E] [/O=NIH/OU=EXCHANGE
ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=Niebylskicd]

cc: Wojtowicz, Emma (NIH/OD) [E] [/O=NIH/OU=EXCHANGE ADMINISTRATIVE GROUP
(FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=Wojtowiczemeéd]; NCI Press Officers
[/O=NIH/OU=NIHEXCHANGE/cn=NCI/cn=ncipressofficers]

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Thanks Mark! ’ve made the change. The background information has been cleared by HHS so will be sharing with Dan
shortly.

Thanks again to all for your input.

Amanda

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, October 31, 2016 10:46 AM

To: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>; Fine,
Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>; Rodriguez, Richard
(NIH/NCI) [E] <richard.rodriguez@nih.gov>; Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>

Ce: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

pote ecsdies cite pentane versie smiperss emt met sbesserbievebienbeeectepabretsr nb easint mibeocmib sb ime noms (enisipenbebemeen sresp mnt pmcbeens meats enews sober seabes sen beauties sisomib a midetomns emeoent dnaveasmnvartesrencenrelsmbeatm cst cmacitetmeetatemtarmsnioasmtatesasarecmrmtaieumtmiatarasatesacmiesarecnen

From: Myles, Renate (NIH/OD) [E]

Sent: Monday, October 31, 2016 10:16 AM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>;
Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>; Rodriguez,
Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>
Cc: Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Just a few more tweaks, including making Kevin's change.

From: Chang, Kevin (NIH/NCI) [E]

Sent: Monday, October 31, 2016 10:06 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>;
Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>; Rodriguez, Richard (NIH/NCI) [E] <richard.redriguez@nih.gov>;
Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>

REL0000024210

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtoewicz@nih.gov>; NCI

Press Officers <ncipressofficers@mail.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

My only comment is that b5

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only for the addressee(s) identified above. If you are not
the addressee(s), or an employee or agent of the addressee(s), please note that any dissemination, distribution, or
copying of this communication is strictly prohibited. If you have received this email in error, please destroy the
document and notify the sender of the error. Thank you.

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, October 31, 2016 10:01 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>; Rodriguez,
Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>; Niebylski,
Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI
Press Officers <ncipressofficers@mail.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Looks good. A couple edits...

From: Fine, Amanda (NIH/OD) [E]

Sent: Monday, October 31, 2016 9:52 AM

To: Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>; Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>;
Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>;
Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>

Ce: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI

Press Officers <ncipressofficers@mail.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Good morning-

iknow i sent the below draft background Information late on Friday evening so just wanted to follow up this morning.

REL0000024210

Thank you in advance for your guidance and input!
Amanda

From: Fine, Amanda (NIH/OD) [E]

Sent: Friday, October 28, 2016 6:11 PM

To: Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>

Cc: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>;
Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI
Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski,

Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>
Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi All-

Sorry for the delay. For your review and input, please see the below draft response:

REL0000024210

Amanda

On Oct 28, 2016, at 11:24 AM, Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov> wrote:

Best regards,

Sue

Susan Ano, Ph.D.

Technology Development Coordinator

Office of Technology Transfer
The National Institute of Neurological Disorders and Stroke

REL0000024210

The National Institutes of Health

Mail address: 31 Center Drive, Suite S852, MiS2546
Bethesda, MD 20892

Physical focation: Bldg. 31, 8407

phone (301)

<image001 jpg>

Have patience. All things are difficult before they become easy.”
- Saadi, poet

The attached information may be confidential, it is intended only for the addressea(s} identified above. if you are nat the addressee(s}, or an employee or agent af
the addressee(s}, please note that any dissernination, distribution, or copying of this communication is strictly prohibited. if you have received this email in error,
please destroy the dacument and notify the sender of the error. Thank you.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:12 AM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI
Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski,
Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>; Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>; Fine, Amanda
(NIH/OD) [E] <amanda.fine@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Richard

From: Chang, Kevin (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:08 AM

To: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Fine, Amanda (NIH/OD) [E]
<amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD)
{E] <RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>; Ano, Susan

(NIH/NINDS) [E] <susan.ano@nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi Richard,

REL0000024210

Sue was working on responses to the questions.

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only for the addressee(s) identified above. If you
are not the addressee(s), or an employee or agent of the addressee(s), please note that any dissemination,
distribution, or copying of this communication is strictly prohibited. If you have received this email in error,
please destroy the document and notify the sender of the error. Thank you.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:04 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD)

[E] <RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>; Ano, Susan
(NIH/NINDS) [E] <susan.ano@nih.gov>; Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi Amanda,

Just saw this and have attached my response to Chuck. If you have more questions,

I'm happy to have a call.
Thanks,

Richard

RICHARD U. RODRIGUEZ, M.BoMo
Associate Director, Technology Transfer Center
Patent Agent

National Cancer Institute

National Institutes of Health

9609 Medical Center Drive, Rm 1E530

Bethesda, MD 20892-9702 (for business mail)
Rockville, MD 20850-9702 (for courier service/visitors)
Phone (Main Office}: 240-276-5530

Direct phone: 240-276-6661

Fax 240-276-5504

richard.rodriquez@nih.gov

httos://tte.neL nih.gov/index.phoa

REL0000024210

“Change is inevitable. Prograss is aptional’ ~ Tony Roberts

Note: This email may contain confidential information. lf you are not the intended recipient, any disclosure,
copying or use of this email or the information enclosed therein is strictly prohibited, and you should notify the
sender for return of any attached documents.

From: Chang, Kevin (NIH/NCI) [E]

Sent: Thursday, October 27, 2016 6:26 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>; Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Ano,
Susan (NIH/NINDS) [E] <susan.ano@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Importance: High

Hi Amanda,

Chuck has also approached me regarding these questions. Richard, Sue, and Mark may be the best
positioned to provide NIH’s official responses on these two questions. Richard should be back from
travel on Monday but | can chat with Mark if he needs background about this specific license.

When do you need the responses to the questions by?

Best regards,
Kevin

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only for the addressee(s) identified above.
if you are not the addressee(s), or an employee or agent of the addressee(s), please note that any
dissemination, distribution, or copying of this communication is strictly prohibited. If you have received
this email in error, please destroy the document and notify the sender of the error. Thank you.

From: Fine, Amanda (NIH/OD) [E]

Sent: Thursday, October 27, 2016 5:03 PM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]

REL0000024210

<emma.wojtowicz@nih.gov>; NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Subject: FW: Interview request/chlorcyclizine pricing: BuzzFeed News
Hi Kevin-

Please see the below long thread about a Buzzfeed inquiry regarding chlorcyclizine as a result of a
complaint by Knowledge Ecology International. As you may know, KEl regularly approaches NIH
regarding Hcensing and exercising march-in rights. We are working to set up an interview with Mark next
week, however wanted to provide the reporter with some background. He asked a few questions about
granting the license that folks said you would know and | was hoping you would help us in drafting
responses to these questions. Specifically the following 2 questions:

2} What are the institute's priorities when licensing these drugs?

(5} Some observers are asking: why grant an exclusive license to a small, unknown company with no
track record of bringing drugs to market?

Please let me know if you have any questions.

Thank you in advance for your help and input!
Amanda

Aranda Fine
Deuiy Oo Branor

of Hacith

: amanda. fine@nih. gov
http://www.nih. gov

NIH... Turning Discovery into Health

From: Fine, Amanda (NIH/OD) [E]

Sent: Thursday, October 27, 2016 3:42 PM

To: Kassilke, Deborah (NIH/OD) [E] <deborah.kassilke@nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Rogers, Karen (NIH/OD) [E] <RogersK@od.nih.gov>

Cc: charles.nybeliski@nih.gov; Niebylski, Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi All-

Just following up on this to see if there was any progress in drafting responses to Dan’s questions. His
deadline is tomorrow.

REL0000024210

{3} How much progress has this licensee made on marketing this drug?

You would need to check with the licensee.

(4) What were the results of the Phase 1 trial that NIH funded on this drug?
These will be published in the near future.

(5) Some observers are asking: why grant an exclusive license to a small, unknown company with no
track record of bringing drugs to market?

Chuck-were you able to speak to Kevin Chang about this?
Thanks to all in advance for your input and guidance.

Best,
Amanda

REL0000024210

From: Kassilke, Deborah (NIH/OD) [E]

Sent: Tuesday, October 25, 2016 11:34 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Rogers, Karen (NIH/OD) [E]
<RogersK@od.nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; charles.nybeliski@nih.gov; Niebylski, Charles
(NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Morning Mark —
You had a bad address for Chuck so I’m adding him in with his NIDDK email.

This is actually for NIDDK to respond as we {OTT} would not feel comfortable answering questions for
NIDDK on their licenses. That said, we will certainly assist NIDDK with the information we can find.

Chuck, fet’s chat on this tomorrow.
Deb

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, October 25, 2016 10:15 AM

To: Kassilke, Deborah (NIH/OD) [E] <deborah.kassilke@nih.gov>; Rogers, Karen (NIH/OD) [E]
<RogersK@od.nih.gov>

Cc: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>; charles.nybeliski@nih.gov

Subject: Fwd: Interview request/chlorcyclizine pricing: BuzzFeed News

Deb and Karen:

Could you please help me follow up on this for Amanda and the press inquiry?! DS.
Thanks
Mark

Sent from my iPhone

Begin forwarded message:

REL0000024210

From: "Rohrbaugh, Mark (NIH/OD) [E]" <RohrBauM@OD.NIH.GOV>
Date: October 24, 2016 at 9:49:59 PM GMT+1

To: "Niebylski, Charles (NIH/NIDDK) [E]" <niebylskicd@niddk.nih.gov>
Ce: "Fine, Amanda (NIH/OD) [E]" <amanda.fine@nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Chuck:

See thread below. Could you help answer the questions about NIH
licensing?

Thanks
Mark

Sent from my iPhone

Begin forwarded message:

From: "Portilla, Lili (NIH/NCATS) [E]"
<portill]@mail.nih.gov>

Date: October 24, 2016 at 9:22:01 PM GMT+1
To: "Rohrbaugh, Mark (NIH/OD) [E]"
<RohrBauM@OD.NIH.GOV>, "Vepa, Sury
(NIH/NCATS) [E]" <sury.vepa@nih.gov>
Subject: RE: Interview request/chlorcyclizine
pricing: BuzzFeed News

Mark:

NIDDK took the lead on this as their Pl ake Liang} was
the biology lead. NCATS has a few co-inventors on the
patent who did screening and med chem. The licensing
for this was done by OTT specifically Kevin

Chang. Chuck Nybeliski was also very involved on the
NCATS side when he was part of our office. | would
speak to him on this matter in his role as Director of the
NIDDK TTO.

Regards,

Lili

LH ML Portilla, MPA

Director, Office of Strategic Alliances

National Center for Advancing Translational Sciences,
AIH

8800 Medical Center Drive, Room 3042

Rockville, MD 20850

Phone: 301-227-2583

REL0000024210

Ema; Lilip@nih.gov

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Monday, October 24, 2016 3:51 PM

To: Driscoll, Claire (NIH/NHGRI) [E]

<cdriscol@mail.nih.gov>; Vepa, Sury (NIH/NCATS) [E]
<sury.vepa@nih.gov>; Portilla, Lili (NIH/NCATS) [E]

<portilll@mail.nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing:
BuzzFeed News

Sorry Claire, meant to copy Lili

Sent from my iPhone

On Oct 24, 2016, at 8:50 PM, Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

wrote:

Sent from my iPhone

Begin forwarded message:

From: "Fine,
Amanda (NIH/OD)
[E]"

<amanda. fine@nih.go
Vv

Date: October 24,
2016 at 8:27:59 PM
GMT+1

To: "Rohrbaugh,
Mark (NIH/OD) [E]"
<RohrBauM@OD.NI
H.GOV>

Ce: "McBurney,
Margaret (NIH/OD)
[E]"
<mmeburney@od.nih
.ov>, "Hardesty,
Rebecca (NIH/OD)
[C]"

REL0000024210

<rebecca.hardesty@ni
h.gov>, "Myles,
Renate (NIH/OD)
[E}"
<mylesr@od.nih.gov
>, "Wojtowicz, Emma
(NIH/OD) [E]"
<emma.wojtowicz@n
ih.gov>

Subject: RE:
Interview
request/chlorcyclizin
e pricing: BuzzFeed
News

Thanks Mark! Hope
you're not working
while on vacation.

REL0000024210

Amanda

From: Rohrbaugh, Mark
(NIH/OD) [E]

Sent: Monday, October
24, 2016 3:22 PM

To: Fine, Amanda
(NIH/OD) [E]
<amanda.fine@nih.gov
>

Cc: McBurney,
Margaret (NIH/OD) [E]
<mmcburney@od.nih.g
ov>; Hardesty, Rebecca
(NIH/OD) [C]
<rebecca.hardesty@nih
.gov>; Myles, Renate
(NIH/OD) [E]
<mylesr@od.nih.gov>;
Wojtowicz, Emma
(NIH/OD) [E]
<emma.wojtowicz@nih
.ZOV>

Subject: Re: Interview
request/chlorcyclizine
pricing: BuzzFeed News

I am available. Looks
ok to me. Not sure
why the email thread
was released under
FOIA. There is more
one could say but this
is the basic

message. | b5

Sent from my iPhone

On Oct 24, 2016, at
8:10 PM, Fine,
Amanda (NIH/OD)
[E]
<amanda.fine@nih.go

v> wrote:

REL0000024210

Greetin
g5-

vm
includin
gall
three of
you per
Mark’s
out of
office
and
given
that the
reporte
r's
deadlin
@ is
Octobe
r28.

NIDDK
receive
d the
below
inquiry
from
Dan
Vergan
oat
Buzzfee
d
regardi
ng
Knowle
dge
Ecology
interna
tional’s
{KE}
questio
ns
about
the
drug
chiorcy
clizine
which
had/ha
$a
small
trial at
the CC.

REL0000024210

Attache
disa
back
and
forth
with
NIDDK/
NCATS
that KEI
got
through
FOIA.
Dan's
questio
ns are
below,

bS

REL0000024210

Nee o ss re it See.

REL0000024210

b5

REL0000024210

you in
advanc
efor
your
input
and
guidanc
e,
Armand

amanda.
fine@ni

—=

h.gov

http://w
ww.nih.
gov

NIH...
Turning
Discove
ry Into
Health

From:
Payne,
January
(NIH/NI
DDK)
{E]
Sent:
Monda
y,
Octobe
r 24,
2016

REL0000024210

Subject

Intervie
w
request
/chlorc
yclizine
pricing:
BuzzFe
ed
News

Hello,
NIDDK
receive
dan
intervie
w
request
froma

REL0000024210

Buzzfe
ed
reporter
asking
about
NIH
involve
ment in
licensin
g and
drug
pricing
for
chlorcy
clizine.
Chuck
Niebyls
ki,
director

NIDDK’
s
Technol
ogy
Advanc
ement
Office,
asked
that |
refer
this
request
to NIH
OD as
it
involve
s NIH’s
policy
on drug
pricing.

Below
is the
complet
e email
exchan
ge I've
had
with the
reporter
, Dan
Vergan
o, and
attache
disa
PDF of
an
email
chain
betwee
n NIH
employ

REL0000024210

ees that
the
reporter
receive
dviaa
public
interest

obtaine
d the
records
viaa
FOIA
request
(Please
note,
for
backgro
und:
KEl
also
publish
ed this
2015
post
about
the

able to
respon
d to this

request
2?

Thank
you,
January
W.
Payne
Office
of
Commu
nication
s and
Public
Liaison
Nationa
|
Institute
of

REL0000024210

Diabete
s and
Digestiv
e and
Kidney
Diseas

ddk.nih
.ZOV
NIH... T
urning
Discov
ery
into
Health
®

Watch
how
medical
researc
h saves
lives
and
improv
es
health

From:

Dan
Vergan

REL0000024210

fo)
[mailto:
dan.ver
ano
buzzfee

Payne,
January
(NIH/NI
DDK)
[E]
<januar
y.payne
@nih.g
ov>
Subject
: Re:
BuzzFe
ed
News:
press
contact

/

licensin
g

Januar
y;

Thanks
for
getting
back to
me

-- The
drug is
chlorcy
clizine
(link to
license
annc't
below)
, and

REL0000024210

the publ
ic
interest
group,
Knowled
ge
Ecology
Internati
onal
(which
often
looks at
NIH
licenses)
is
complain
ing that
its
request
for
"reasona
ble
pricing"
requirem
ents in
the
license
were
brushed
aside to
the
detrimen
tof
taxpayer
s. The
group
has just
received
a public
records
request
(a
portion
is
attached)
and
suggests
they
show
that NIH
is
worried
more
about
scaring
off the
licensee
than
benefitin
g the
taxpayer
s who
funded
this drug
and have

REL0000024210

no
assurane
e they
won't
have to
pay
excessiv
ely high
prices
for it.

-- I'm
looking
for an
agency
response
to this
contentio
n.

-- My
deadline
is
10/28/16
at 5 PM
EDT

ie My
questions
would
basically
be:

How do
you
respond
to their
complain
22

What are
the
institute’
$
priorities
when
licensing
these
drugs?
How
much
progress
has this
licensee
made on
marketin
g this
drug?
What
were the
results of
the
Phase 1
trial that
NIH
funded

REL0000024210

on this
drug?
Some
observ
ers are
asking:
why
grant
an
exclusi
ve
license
toa
small,
unkno
wn
compa
ny
with
no
track
record
of
bringin
g drugs

I'd
have
follow-
ups
depend
ing on
the
answer
8,
natch,
and
would
want to
hear
any
respon
ses to
smarter
questio
ns on
all this
that
your

REL0000024210

folks
might
have.

Any help
appreciat
ed,

Dan
Vergano
BuzzFee
d News
202 629
4563

REL0000024210

629
4563
BuzzFs
ed
1630
Connec
ticut
Ave.

Mon,
Oct 24,
2016 at
11:57
AM,
Payne,
Januar

y
(NIH/
NIDD
K) [E]
<janua
ry.pay
ne@ni
h.gov>
wrote:

Dear
Dan,

Thank
s for
your
messa
ge.
Can
you
please
provid
e
more
inform
ation
so |

REL0000024210

can
look
into
your
reques
t?

e 6W
hat is
the
drug
name,
and
can
you
please
briefly
descri
be the
issue
that
has
been
raised
? Also,
what
is the
name
of the
public
interes
t

group
?

e W
hat is
your
hard
deadli
ne?

e C
an you
please
provid
ea

few

examp
les of
questi
ons

you’d

REL0000024210

like to
ask?

Best,

Januar
y W.
Payne

Office
of
Comm
unicati
ons
and
Public
Liaiso
n
Nation
a
Institut
e of
Diabet
es and
Digesti
ve and
Kidney
Diseas
es

NATIO
NAL

8
Discov
ery
Inte
Health
&

REL0000024210

Weatcn
how
medic
al
resear
ch
Saves
lives
and
impre
ves
health

From:
Dan
Verga
no
[mailt
o:dan.
vergan
o@bu
zzfeed
com]
Sent:
Mond
ay,
Octob
er 24,
2016
11:25
AM
To:
NIDDK
NIDDK
MEDIA
(NIH/
NIDDK
)
<niddk
media
@nidd
k.nih.g
ov>

REL0000024210

Subjec
t: Fwd:
BuzzFe
ed
News:
press
contac
t/
licensi
ng

Kryst
en's
email
respo
nder
sugge
sted IJ
send
this
note
to this
conta
ct. I
have
also
left a
phone
messa
ge
with
the
press
office.
Iam
lookin
g for
comm
ent
this
week.

Ms.
Carrer
a,

Ima
scienc

REL0000024210

who
can
addre
ssa
drug
licens
ing
issuc
at
your
institu
te. A
public
intere
st
group
is
raisin
& .
questi
ons
about
one of
your
licens
es and
I'd
like to
geta
respo
nse
from
the
institu
te.

REL0000024210

Thank
s for
any
help,

Dan
Verga
no

Buzz
Feed
News

202/6

29-
4563

Dan
Verga
no |
Scienc

REL0000024210

JANUARY PAYNE

@ National Institutes of Health

National Institutes of Health | 9000 Rockville Pike, Bethesda, MD 20892, USA | Official
(NIH). NIH is one of the world's foremost medical research centers. An agency of...

January Payne on LinkedIn

@NIH | 663K followers | 6K tweets - ©

There's still time to submit your 2°Ni8_LRF application! Get started on yours today.

Sstudentdebt

= Search for January Payne on Google

<Reas
onable
Pricing

Virotas
NIH
.pdf>
<image001.jpg>
<image001 .jpg>
<image001 jpg>
<image001 .jpg>

REL0000024210

From: Fine, Amanda (NIH/OD) [E

To: Rohrbaugh, Mark (NIH/OD) [E

Cec: Myles, Renate (NIH/OD) [E

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News
Date: Wednesday, November 2, 2016 9:05:38 AM

Yes that is perfect! We can do the call from Renate’s polycom.

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Wednesday, November 02, 2016 10:02 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Feeling better. Thx I will be coming in. Is 11:45 enough time? I could stop by

Sent from my iPhone

On Nov 2, 2016, at 9:55 AM, Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov> wrote:
Hi Mark-

Just checking in to see if you are (6) 6) and up for the call with Dan Vergano today.

Renate and | were hoping to chat prior to your interview at noon so let us know when would be a
good time to meet or give you a call. Dan gave us his number to call: (6) (6), however we can
have him call you if you prefer just let me know what number | should provide him.

Thank you again and hope you're feeling better!
Amanda

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, November 01, 2016 10:08 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

How about noon to 3?
Sent from my iPhone
On Nov 1, 2016, at 10:02 AM, Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov> wrote:

Oh no I’m sorry to hear that! I’m sure we can arrange that. Is there a time | should
offer? | will also let him know (b) (6).

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, November 01, 2016 10:01 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Today? ()(6) Can we do it tomorrow?

Sent from my iPhone

On Oct 31, 2016, at 1:59 PM, Fine, Amanda (NIH/OD) [E]
<amanda.fine@nih.gov> wrote:

Hi Mark-

Wasn’t sure if you saw my below email. Is there a time tomorrow that
would work for you to speak with Dan?

Thanks again!
Amanda

From: Fine, Amanda (NIH/OD) [E]

Sent: Monday, October 31, 2016 9:55 AM

To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma
(NIH/OD) [E] <emma.wojtowicz@nih.gov>

Subject: FW: Interview request/chlorcyclizine pricing: BuzzFeed News

Good morning and welcome back!

| wanted to check in to see what your availability is to speak to Dan either
later today or sometime tomorrow. We’re hoping to provide him with the
background information prior to speaking with you.

Thanks!
Amanda

From: Fine, Amanda (NIH/OD) [E]

Sent: Friday, October 28, 2016 6:11 PM

To: Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>

Ce: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Chang,
Kevin (NIH/NCI) [E] <changke@mail.nih.gov>; Myles, Renate (NIH/OD) [E]
<mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers
<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi All-

Sorry for the delay. For your review and input, please see the below
draft response:

Thanks!
Amanda

On Oct 28, 2016, at 11:24 AM, Ano, Susan (NIH/NINDS) [E]
<susan.ano@nih.gov> wrote:

There’s a typo in the email below. The first statement should read

Best regards,

Sue

Susan Ano, Ph.D.

Technology Development Coordinator

Office of Technology Transfer

The National Institute of Neurological Disorders and Stroke
The National Institutes of Health

Mail address: 31 Center Drive, Suite 8A52, MS2540
Bethesda, MD 20892

Physical location: Bldg. 31, 8A07

phone (301) 435-5515

col NEO

<image001.jpg>

Have patience. All things are difficult before they become
easy."
-- Saadi, poet

The attached information may be confidential. It is intended only for the addressee(s) identified
above. If you are not the addressee(s), or an employee or agent of the addressee(s), please note that
any dissemination, distribution, or copying of this communication is strictly prohibited. If you have
received this email in error, please destroy the document and notify the sender of the error. Thank
you.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:12 AM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma
(NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press Officers
<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]

<niebylskicd@niddk.nih.gov>; Ano, Susan (NIH/NINDS) [E]
<susan.ano@nih.gov>; Fine, Amanda (NIH/OD) [E]

<amanda.fine@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Richard

From: Chang, Kevin (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:08 AM

To: Rodriguez, Richard (NIH/NCI) [E]
<richard.rodriguez@nih.gov>; Fine, Amanda (NIH/OD) [E]
<amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz,
Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press
Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski, Charles
(NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>; Ano, Susan
(NIH/NINDS) [E] <susan.ano@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed
News

Hi Richard,

Sue was working on responses to the questions.

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only
for the addressee(s) identified above. If you are not the
addressee(s), or an employee or agent of the addressee(s), please
note that any dissemination, distribution, or copying of this
communication is strictly prohibited. If you have received this
email in error, please destroy the document and notify the sender
of the error. Thank you.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:04 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz,

Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press
Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski, Charles
(NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>; Ano, Susan
(NIH/NINDS) [E] <susan.ano@nih.gov>; Chang, Kevin (NIH/NCI) [E]
<changke@mail.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed
News

Hi Amanda,

Just saw this and have attached my response to
Chuck. If you have more questions, I'm happy to
have a call.

Thanks,

Richard

RICHARD U. RODRIGUEZ, M.B.A.
Associate Director, Technology Transfer Center
Patent Agent

National Cancer Institute

National Institutes of Health

9609 Medical Center Drive, Rm 1E530

Bethesda, MD 20892-9702 (for business mail)
Rockville, MD 20850-9702 (for courier service/visitors)
Phone (Main Office): 240-276-5530

Direct phone: 240-276-6661

Fax 240-276-5504

richard.rodriguez@nih.gov

https://ttc.nci.nih.gov/index.ph
“Change is inevitable. Progress is optional” — Tony Roberts

Note: This email may contain confidential information. If you
are not the intended recipient, any disclosure, copying or use of
this email or the information enclosed therein is strictly
prohibited, and you should notify the sender for return of any
attached documents.

From: Chang, Kevin (NIH/NCI) [E]

Sent: Thursday, October 27, 2016 6:26 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>
Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>;
Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers

<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski,
Charles (NIH/NIDDK) [E] <niebylskicd @niddk.nih.gov>;
Rodriguez, Richard (NIH/NCI) [E]
<richard.rodriguez@nih.gov>; Ano, Susan (NIH/NINDS) [E]
<susan.ano@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing:
BuzzFeed News
Importance: High

Hi Amanda,

Chuck has also approached me regarding these
questions. Richard, Sue, and Mark may be the best
positioned to provide NIH’s official responses on these
two questions. Richard should (b) (6) on
Monday but | can chat with Mark if he needs background
about this specific license.

When do you need the responses to the questions by?

Best regards,
Kevin

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is
intended only for the addressee(s) identified above. If you
are not the addressee(s), or an employee or agent of the
addressee(s), please note that any dissemination,
distribution, or copying of this communication is strictly
prohibited. If you have received this email in error, please
destroy the document and notify the sender of the error.
Thank you.

From: Fine, Amanda (NIH/OD) [E]

Sent: Thursday, October 27, 2016 5:03 PM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>
Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>;
Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers

<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark
(NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Subject: FW: Interview request/chlorcyclizine pricing:
BuzzFeed News

Hi Kevin-

Please see the below long thread about a Buzzfeed
inquiry regarding chlorcyclizine as a result of a complaint
by Knowledge Ecology International. As you may know,
KEI regularly approaches NIH regarding licensing and
exercising march-in rights. We are working to set up an
interview with Mark next week, however wanted to
provide the reporter with some background. He asked a
few questions about granting the license that folks said
you would know and | was hoping you would help us in
drafting responses to these questions. Specifically the
following 2 questions:

2) What are the institute's priorities when licensing these
drugs?

(5) Some observers are asking: why grant an exclusive
license to a small, unknown company with no track record
of bringing drugs to market?

Please let me know if you have any questions.

Thank you in advance for your help and input!
Amanda

Amanda Fine

Deputy, News Media Branch
National Institutes of Health
Tel: 301-496-7246

Email: amanda fine@nih.gov
Web: http://www.nih.gov

NIH... Turning Discovery Into Health

From: Fine, Amanda (NIH/OD) [E]
Sent: Thursday, October 27, 2016 3:42 PM
To: Kassilke, Deborah (NIH/OD) [E]

<deborah.kassilke@nih.gov>; Rohrbaugh, Mark (NIH/OD)

ha lis ih.gov; Niebylski, Charles
(NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing:
BuzzFeed News

Hi All-

Just following up on this to see if there was any progress
in drafting responses to Dan’s questions. His deadline is
tomorrow.

As I mentioned before, [IIe

(2) What are the institute's priorities when licensing these
drugs?

(3) How much progress has this licensee made on
marketing this drug?

You would need to check with the licensee.

(4) What were the results of the Phase 1 trial that NIH
funded on this drug?

These will be published in the near future.

(5) Some observers are asking: why grant an exclusive
license to a small, unknown company with no track record
of bringing drugs to market?

Chuck-were you able to speak to Kevin Chang about this?

Thanks to all in advance for your input and guidance.

Best,
Amanda

From: Kassilke, Deborah (NIH/OD) [E]

Sent: Tuesday, October 25, 2016 11:34 AM

To: Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Rogers, Karen (NIH/OD) [E]
<RogersK@od.nih.gov>

Ce: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>;
charles.nybeliski@nih.gov; Niebylski, Charles (NIH/NIDDK)
[E] <niebylskicd @niddk.nit

Subject: RE: Interview request/chlorcyclizine pricing:
BuzzFeed News

Morning Mark —

You had a bad address for Chuck so I’m adding him in with
his NIDDK email.

This is actually for NIDDK to respond as we (OTT) would
not feel comfortable answering questions for NIDDK on
their licenses. That said, we will certainly assist NIDDK
with the information we can find.

Chuck, let’s chat on this tomorrow.
Deb

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, October 25, 2016 10:15 AM

To: Kassilke, Deborah (NIH/OD) [E]
<deborah.kassilke@nih.gov>; Rogers, Karen (NIH/OD) [E]
<RogersK@od.nih.gov>

Ce: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>;
charles.nybeliski@nih.gov

Subject: Fwd: Interview request/chlorcyclizine pricing:
BuzzFeed News

Deb and Karen:

Could you please help me follow up on this for
Amanda and the inqui

Thanks
Mark

Sent from my iPhone

Begin forwarded message:

From: "Rohrbaugh, Mark (NIH/OD) [E]"
<RohrBauM@OD.NIH.GOV>

Date: October 24, 2016 at 9:49:59 PM
GMT+1

To: "Niebylski, Charles (NIH/NIDDK)
[E]" <niebylskicd@niddk.nih.gov>
Ce: "Fine, Amanda (NIH/OD) [E]"
<amanda.fine@nih.gov>

Subject: Re: Interview
request/chlorcyclizine pricing:
BuzzFeed News

Chuck:

See thread below. Could you
help answer the questions
about NIH licensing?

Thanks
Mark

Sent from my iPhone
Begin forwarded message:

From: "Portilla,

Lili

(NIH/NCATS)

[E]"
<portilll@mail.nih.gov>
Date: October

24, 2016 at

9:22:01 PM

GMT+1

To: "Rohrbaugh,

Mark (NIH/OD)

[E]"
<RohrBauM@OD.NIH.GOV>,
"Vepa, Sury
(NIH/NCATS)

[E]"
<sury.vepa@nih.gov>
Subject: RE:
Interview

request/chlorcyclizine
pricing:
BuzzFeed News

Mark:

NIDDK took the
lead on this as
their PI (Jake
Liang) was the
biology lead.
NCATS has a few
co-inventors on
the patent who
did screening and
med chem. The
licensing for this
was done by OTT
specifically Kevin
Chang. Chuck
Nybeliski was also
very involved on
the NCATS side
when he was part
of our office. |
would speak to
him on this
matter in his role
as Director of the
NIDDK TTO.

Regards,

Lili

Lili M. Portilla,
MPA

Director, Office of
Strategic Alliances
National Center
for Advancing
Translational
Sciences, NIH
9800 Medical
Center Drive,
Room 3042
Rockville, MD
20850

Phone: 301-217-
2589

Email:

Lilip@nih.gov

From: Rohrbaugh,
Mark (NIH/OD) [E]
Sent: Monday,
October 24, 2016
3:51 PM

To: Driscoll, Claire
(NIH/NHGRI) [E]
<cdriscol@mail.nih.gov>;
Vepa, Sury
(NIH/NCATS) [E]
<sury.vepa@nih.gov>;

Portilla, Lili
(NIH/NCATS) [E]
<portilll@ mail. nih.gov>
Subject: Re:

Interview

request/chlorcyclizine
pricing: BuzzFeed
News

Sorry Claire,
meant to copy
Lili

Sent from my
iPhone

On Oct 24, 2016,

at 8:50 PM,

Rohrbaugh,

Mark (NIH/OD)

[E]
<RohrBauM@OD.NIH.GOV>
wrote:

Sent
from

my
iPhone

Begin
forwarded
message:

From:

"Fine,

Amanda

(NIH/OD)

[E]"
<amanda.fine@nih.gov>
Date:

October

To:

"Rohrbaugh,

Mark

(NIH/OD)

[E] "W
<RohrBauM@OD.NIH.GOV>
Ce:

"McBurney,

Margaret

(NIH/OD)

[E] "
<mmeburney@od.nih.gov>,
"Hardesty,

Rebecca

(NIH/OD)

[C] "
<rebecca.hardesty@nih.gov>,
"Myles,

Renate

(NIH/OD)

[EF] "

<mylesr@od.nih.gov>,

"Wojtowicz,

Emma

(NIH/OD)

[E]"
<emma.wojtowicz@nih.gov>
Subject:

RE:

Interview
request/chlorcyclizine
pricing:

BuzzFeed

News

Thanks
Mark!
Hope
you're
not
working
while

on
vacation.

Amanda

From:
Rohrbaugh,
Mark
(NIH/OD)
[E]

Sent:
Monday,
October
24,

2016
3:22

PM

To:

Fine,
Amanda
(NIH/OD)
[E]

<amanda.fine@nih.gov>
Cc:

McBurney,

Margaret

(NIH/OD)

[E]
<mmcburney@od.nih.gov>;
Hardesty,

Rebecca

(NIH/OD)

[C]
<rebecca.hardesty@nih.gov>;
Myles,

Renate

(NIH/OD)

[E]

<mylesr@od.nih.gov>;
Wojtowicz,

Emma

(NIH/OD)

[E]
<emma.wojtowicz@nih.gov>
Subject:

Re:

Interview
request/chlorcyclizine
pricing:

BuzzFeed

News

I

am

available.
Looks

ok

Not
sure
why
the
email
thread
was
released
under
FOIA.

There
iS
more
one
could

say
but
this
1S
the
basic

message.

<amanda.fine@nih.gov>
wrote:

Greetings-

I’m
including
all

three

of

you

per
Mark’s
out

of

office
and
given
that

the
reporter’s
deadline
is
October
28.

NIDDK
received
the

below
inquiry
from

Dan
Vergano
at
Buzzfeed
regarding
Knowledge
Ecology
International’s
(KE!)
questions
about

the

drug
chlorcyclizine
which
had/has

a

small

trial

at

the

CC.
Attached
is

a
back

and

forth

with
NIDDK/NCATS
that

KEI

got

through
FOIA.

Dan’s
questions

are

below

advance
for

your
input
and
guidance,
Amanda

Amanda
Fine
Deputy,
News
Media
Branch
National
Institutes

amanda fine@nih.gov
Web:

http://www nih.gov

NIH

Turning
Discovery
Into
Health

From:

Payne,

January
(NIH/NIDDK)

[E]

Sent:

Monday,
October

24,

2016

2:54

PM

To:
OCPLPressTeam
<OCPLPressTeam@od.nih.gov>;

ODOCPL
Interviews
(NIH/OD
OCPL

)

<QDOCPLInterviews@mail.nih.gov>
Cc:

NIDDK
NIDDKMEDIA
(NIH/NIDDK)

<niddkmedia@niddk.nih.gov>
Subject:

Interview
request/chlorcyclizine
pricing:

BuzzFeed

News

Hello,
NIDDK
received
an
interview
request
from

a
Buzzfeed
reporter
asking
about
NIH
involvement
in
licensing
and

drug
pricing
for
chlorcyclizine.
Chuck
Niebylski,
director
of
NIDDK’s
Technology
Advancement
Office,
asked
that

I

refer

this
request
to

NIH

OD

as

it
involves

NIH’s
policy
on
drug
pricing.

Below

is

the
complete
email
exchange
I’ve

had

with

the
reporter,
Dan
Vergano,
and
attached

an
email

chain
between
NIH
employees
that

the
reporter
received
via

a

public
interest
group
called
Knowledge

Ecology
International,

which
obtained
the
records
via

a

FOIA
request.
(Please
note,

for
background:
KEI

also

published

same
drug.)

Is

NIH

OD

able

to
respond
to

this
request?

Thank
you,
January
Ww.
Payne
Office
of
Communications
and
Public
Liaison
National
Institute
of
Diabetes
and
Digestive
and
Kidney
Diseases
NATIONAL
INSTITUTES
OF
HEALTH
Direct
301-
435-
8115
Cell

(b) (6)

Office
301-
496-
3583

www.niddk.nih.gov
NIH...Turning

Discovery
Into

Health®

[-2]

Celebration
of
Science

medical
research
saves
lives

and
improves
health

From:

Dan

Vergano
[mailto:dan.vergano@buzzfeed.com]
Sent:

Monday,

October

24,

2016

12:29

PM

To:

Payne,

January

(NIH/NIDDK)

[E]
<january.payne@nih.gov>
Subject:

Re:

BuzzFeed

News:
press
contact
/

licensing
January,

Thanks
for
getting
back

10/28/16

lanl
eoZza _alvlvscslate.

deadline

lal ledorezclotscclsie. _ cdecllas! 2

1

3

2

slisistatbeclas!cb2selecd ossdes®@iclet. 1... 2.38.08.2 DES

ups
depending
on

the
answers,
natch,
and
would
want

to

hear

any
responses
to
smarter
questions
on

all

this

that

your
folks
might
have.

Any
help
appreciated,

Dan
Vergano
BuzzFeed
News
202

BuzzFeed

1630
Connecticut

Floor,
Washington
DC

20009

link:
https://s3.amazonaws.com/public-
inspection.federalregister.gov/2015-
06974.pdf

Dan
Vergano

Science
Reporter
(DC)

|

202

629
4563

BuzzFeed

1630
Connecticut
Ave.

7th

Floor,
Washington
DC

20009

On

Mon,

Oct

24,

2016

at

11:57

AM,

Payne,
January
(NIH/NIDDK)
[E]
<january.payne@nih.gov>
wrote:

Dear
Dan,

Thanks
for

your
message.
Can

you
please
provide
more

information
ie)

|

can

look

into

your
request?

you
please
briefly
describe
the
issue
that

has
been
raised?
Also,
what

the
public
interest
group?

e

What

is

your
hard
deadline?

e

Can
you
please
provide
a

few

examples
of
questions
you’d

like

to

ask?

Best,
January

Ww.

Payne
Office

of
Communications
and

Public
Liaison
National
Institute

of

Diabetes
and
Digestive
and

Kidney
Diseases
NATIONAL
INSTITUTES
OF
HEALTH

www.niddk.nih.gov
NIH...Turning
Discovery

Into

Health®

Ls]

Celebration
of

Science

at

NIH:
Watch
how
medical
research
saves
lives

and
improves
health

From:

Dan

Vergano
[mailto:dan.vergano@buzzfeed.com]
Sent:

Monday,

October

24,

2016

14:25

AM

To:

NIDDK

NIDDKMEDIA

(NIH/NIDDK)
<niddkmedia@niddk.nih.gov>
Subject:

Fwd:

BuzzFeed

News:
press
contact

/

licensing

Krysten's
email
responder
suggested
I

send

this

note

to

this
contact.

I

have

also

left

a

phone
message
with

the

press
office.

I

am
looking
for
comment
this
week.

Ms.

Carrera,

Vergano
BuzzFeed
News
202/629-
4563

Connecticut

7th

Floor,
Washington
DC

20009

JANUARY Senders
PAYNE Card

@ National
Institutes of
Health

National Institutes of
Health | 9000 Rockville
Pike, Bethesda, MD
20892, USA | Official
website of the National
Institutes of Health (NIH).
NIH is one of the world’s
foremost medical
research centers. An
agency of...

@NIH | 663K
followers |

6K tweets - 5

I ours ago
There's still time to
submit your
QNIH_LRP

ication! Get

started on yours
today. Deadline is
Nov.15
bit.ly/2e7QDzt
“studentdebt

Search for
January Payne

using
Senders

<Reasonable
Pricing

Virotas
NIH
.pdf>
<image001.jpg>
<image001.jpg>
<image001.jpg>
<image001.jpg>

From: Fine, Amanda (NIH/OD) [E

To: Rohrbaugh, Mark (NIH/OD) [E

Cc: Myles, Renate (NIH/OD) [E]; Wojtowicz, Emma (NIH/OD) [E
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News
Date: Tuesday, November 1, 2016 10:07:16 AM

Hi Mark-

Dan confirmed tomorrow at 12pm to speak with you.

Thanks!
Amanda

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, November 01, 2016 10:08 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

How about noon to 3?
Sent from my iPhone

On Nov 1, 2016, at 10:02 AM, Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov> wrote:
Oh no |’m sorry to hear that! I’m sure we can arrange that. Is there a time | should offer? |

will also let him know (b) (6)

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, November 01, 2016 10:01 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Today? ()() Can we do it tomorrow?

Sent from my iPhone

On Oct 31, 2016, at 1:59 PM, Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>
wrote:

Hi Mark-

Wasn't sure if you saw my below email. Is there a time tomorrow that would
work for you to speak with Dan?

Thanks again!
Amanda

From: Fine, Amanda (NIH/OD) [E]
Sent: Monday, October 31, 2016 9:55 AM
To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma
(NIH/OD) [E] <emma.wojtowicz@nih.gov>

Subject: FW: Interview request/chlorcyclizine pricing: BuzzFeed News

Good morning and welcome back!

| wanted to check in to see what your availability is to speak to Dan either later
today or sometime tomorrow. We’re hoping to provide him with the
background information prior to speaking with you.

Thanks!
Amanda

From: Fine, Amanda (NIH/OD) [E]

Sent: Friday, October 28, 2016 6:11 PM

To: Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>

Ce: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Chang, Kevin
(NIH/NCI) [E] <changke@mail.nih.gov>; Myles, Renate (NIH/OD) [E]
<mylesr@od.nih.gov>; Wojtowicz, Emma (NIH/OD) [E]
<emma.wojtowicz@nih.gov>; NCI Press Officers
<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>

Subject: Re: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi All-

Sorry for the delay. For your review and input, please see the below draft
response:

Thanks!
Amanda

On Oct 28, 2016, at 11:24 AM, Ano, Susan (NIH/NINDS) [E]
<susan.ano@nih.gov> wrote:

There’s a typo in the email below. The first statement should read I O@

Best regards,

Sue

Susan Ano, Ph.D.

Technology Development Coordinator

Office of Technology Transfer

The National Institute of Neurological Disorders and Stroke

The National Institutes of Health

Mail address: 31 Center Drive, Suite 8A52, MS2540
Bethesda, MD 20892

Physical location: Bldg. 31, 8A07

phone (301) 435-5515

cel IO

<image001.jpg>

Have patience. All things are difficult before they become easy."
-- Saadi, poet

The attached information may be confidential. It is intended only for the addressee(s) identified above. If you
are not the addressee(s), or an employee or agent of the addressee(s), please note that any dissemination,
distribution, or copying of this communication is strictly prohibited. If you have received this email in error,
please destroy the document and notify the sender of the error. Thank you.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:12 AM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Ce: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma
(NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press Officers
<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>; Ano, Susan (NIH/NINDS) [E]
<susan.ano@nih.gov>; Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>
Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Richard

From: Chang, Kevin (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:08 AM

To: Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>; Fine,
Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma
(NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press Officers
<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>; Ano, Susan (NIH/NINDS) [E]

<susan.ano@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News

Hi Richard,

Sue was working on responses to the questions.

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only for the
addressee(s) identified above. If you are not the addressee(s), or an
employee or agent of the addressee(s), please note that any
dissemination, distribution, or copying of this communication is strictly
prohibited. If you have received this email in error, please destroy the
document and notify the sender of the error. Thank you.

From: Rodriguez, Richard (NIH/NCI) [E]

Sent: Friday, October 28, 2016 11:04 AM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>; Wojtowicz, Emma
(NIH/OD) [E] <emma.wojtowicz@nih.gov>; NCI Press Officers
<ncipressofficers@mail.nih.gov>; Rohrbaugh, Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>; Ano, Susan (NIH/NINDS) [E]
<susan.ano@nih.gov>; Chang, Kevin (NIH/NCI) [E]
<changke@mail.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed News
Hi Amanda,
Just saw this and have attached my response to

Chuck. If you have more questions, I'm happy to have
a call.

Thanks,

Richard

RICHARD U. RODRIGUEZ, M.B.A.
Associate Director, Technology Transfer Center
Patent Agent

National Cancer Institute

National Institutes of Health

9609 Medical Center Drive, Rm 1E530

Bethesda, MD 20892-9702 (for business mail)
Rockville, MD 20850-9702 (for courier service/visitors)
Phone (Main Office): 240-276-5530

Direct phone: 240-276-6661

Fax 240-276-5504

richard. rodri Z@nih.gov

https://ttc.nci.nih.gov/index.ph
“Change is inevitable. Progress is optional” — Tony Roberts

Note: This email may contain confidential information. If you are not
the intended recipient, any disclosure, copying or use of this email or
the information enclosed therein is strictly prohibited, and you should
notify the sender for return of any attached documents.

From: Chang, Kevin (NIH/NCI) [E]

Sent: Thursday, October 27, 2016 6:26 PM

To: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>;
Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>;
NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh,
Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>; Niebylski,
Charles (NIH/NIDDK) [E] <niebylskicd@niddk.nih.gov>;
Rodriguez, Richard (NIH/NCI) [E] <richard.rodriguez@nih.gov>;
Ano, Susan (NIH/NINDS) [E] <susan.ano@nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed
News

Importance: High

Hi Amanda,

Chuck has also approached me regarding these questions.
Richard, Sue, and Mark may be the best positioned to provide

NIH’s official responses on these two questions. Richard should
(6) 6) on Monday but | can chat with Mark if he
needs background about this specific license.

When do you need the responses to the questions by?

Best regards,
Kevin

Kevin W. Chang, Ph.D.

Senior Licensing and Patenting Manager
NCI Technology Transfer Center

9609 Medical Center Dr.

Room 3W-128, MSC 9702

Rockville, MD 20850-9702

Phone: 240-276-6910

Email: changke@mail.nih.gov

The attached information may be confidential. It is intended only
for the addressee(s) identified above. If you are not the
addressee(s), or an employee or agent of the addressee(s),
please note that any dissemination, distribution, or copying of
this communication is strictly prohibited. If you have received
this email in error, please destroy the document and notify the
sender of the error. Thank you.

From: Fine, Amanda (NIH/OD) [E]

Sent: Thursday, October 27, 2016 5:03 PM

To: Chang, Kevin (NIH/NCI) [E] <changke@mail.nih.gov>

Cc: Myles, Renate (NIH/OD) [E] <mylesr@od.nih.gov>;
Wojtowicz, Emma (NIH/OD) [E] <emma.wojtowicz@nih.gov>;
NCI Press Officers <ncipressofficers@mail.nih.gov>; Rohrbaugh,
Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>

Subject: FW: Interview request/chlorcyclizine pricing: BuzzFeed
News

Hi Kevin-

Please see the below long thread about a Buzzfeed inquiry
regarding chlorcyclizine as a result of a complaint by Knowledge
Ecology International. As you may know, KEI regularly
approaches NIH regarding licensing and exercising march-in
rights. We are working to set up an interview with Mark next
week, however wanted to provide the reporter with some
background. He asked a few questions about granting the

license that folks said you would know and | was hoping you
would help us in drafting responses to these questions.
Specifically the following 2 questions:

2) What are the institute's priorities when licensing these drugs?

(5) Some observers are asking: why grant an exclusive license to
a small, unknown company with no track record of bringing
drugs to market?

Please let me know if you have any questions.

Thank you in advance for your help and input!
Amanda

Amanda Fine

Deputy, News Media Branch
National Institutes of Health
Tel: 301-496-7246

Email: amanda fine@nih. gov
Web: http://www nih.gov

NIH ... Turning Discovery Into Health

From: Fine, Amanda (NIH/OD) [E]

Sent: Thursday, October 27, 2016 3:42 PM

To: Kassilke, Deborah (NIH/OD) [E] <deborah.kassilke@nih.gov>;
Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GOV>;
Rogers, Karen (NIH/OD) [E] <RogersK@od.nih.gov>

Ce: charles.nybeliski@nih.gov; Niebylski, Charles (NIH/NIDDK) [E]
<niebylskicd@niddk.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed
News

Hi All-

Just following up on this to see if there was any progress in
drafting responses to Dan’s questions. His deadline is tomorrow.

As | mentioned before,

(2) What are the institute's priorities when licensing these
drugs?

(3) How much progress has this licensee made on marketing this
drug?

You would need to check with the licensee.

(4) What were the results of the Phase 1 trial that NIH funded on
this drug?

These will be published in the near future.
(5) Some observers are asking: why grant an exclusive license to

a small, unknown company with no track record of bringing
drugs to market?

Chuck-were you able to speak to Kevin Chang about this?
Thanks to all in advance for your input and guidance.

Best,
Amanda

From: Kassilke, Deborah (NIH/OD) [E]

Sent: Tuesday, October 25, 2016 11:34 AM
To: Rohrbaugh, Mark (NIH/OD) [E] <RohrBauM@OD.NIH.GO
Rogers, Karen (NIH/OD) [E] <RogersK@od.nih.gov>

Ja. HNe(UNIn. gov;

MV

Ce: Fine, Amanda (NIH/OD) [E] <aman

charles.nybeliski@nih.gov; Niebylski, Charles (NIH/NIDDK) [E]
<niebylski niddk.nih.gov>

Subject: RE: Interview request/chlorcyclizine pricing: BuzzFeed
News

Morning Mark —

You had a bad address for Chuck so I’m adding him in with his
NIDDK email.

This is actually for NIDDK to respond as we (OTT) would not feel
comfortable answering questions for NIDDK on their licenses.
That said, we will certainly assist NIDDK with the information we
can find.

Chuck, let’s chat on this tomorrow.
Deb

From: Rohrbaugh, Mark (NIH/OD) [E]

Sent: Tuesday, October 25, 2016 10:15 AM

To: Kassilke, Deborah (NIH/OD) [E] <deborah.kassilke@nih.gov>;
Rogers, Karen (NIH/OD) [E] <RogersK@od.nih.gov>

Ce: Fine, Amanda (NIH/OD) [E] <amanda.fine@nih.gov>;
charles.nybeliski@nih.gov

Subject: Fwd: Interview request/chlorcyclizine pricing: BuzzFeed
News

Deb and Karen:

Could you please help me follow up on this for Amanda and
the press inquiry?

Thanks
Mark

Sent from my iPhone

Begin forwarded message:

From: "Rohrbaugh, Mark (NIH/OD) [E]"
<RohrBauM@OD.NIH.GOV>

Date: October 24, 2016 at 9:49:59 PM GMT+1
To: "Niebylski, Charles (NIH/NIDDK) [E]"

<niebylskicd@niddk.nih.gov>
Ce: "Fine, Amanda (NIH/OD) [E]"

<amanda.fine@nih.gov>

Subject: Re: Interview request/chlorcyclizine
pricing: BuzzFeed News

Chuck:

See thread below. Could you help
answer the questions about NIH
licensing?

Thanks
Mark

Sent from my iPhone

Begin forwarded message:

From: "Portilla, Lili
(NIH/NCATS) [E]"
<portilll@mail.nih.gov>
Date: October 24,

2016 at 9:22:01 PM
GMT+1

To: "Rohrbaugh, Mark
(NIH/OD) [E]"
<RohrBauM@OD.NIH.GOV>,
"Vepa, Sury
(NIH/NCATS) [E]"
<sury.vepa@nih.gov>
Subject: RE:
Interview
request/chlorcyclizine
pricing: BuzzFeed
News

Mark:

NIDDK took the lead on
this as their Pl Jake
Liang) was the biology
lead. NCATS has a few
co-inventors on the
patent who did
screening and med
chem. The licensing for
this was done by OTT
specifically Kevin Chang.
Chuck Nybeliski was also
very involved on the
NCATS side when he was
part of our office. |

would speak to him on
this matter in his role as
Director of the NIDDK
TTO.

Regards,

Lili

Lili M. Portilla, MPA
Director, Office of
Strategic Alliances
National Center for
Advancing Translational
Sciences, NIH

9800 Medical Center
Drive, Room 3042
Rockville, MD 20850
Phone: 301-217-2589

Email: Lilip@nih.gov

From: Rohrbaugh, Mark
(NIH/OD) [E]

Sent: Monday, October
24, 2016 3:51 PM

To: Driscoll, Claire
(NIH/NHGRI) [E]
<cdriscol@mail.nih.gov>;
Vepa, Sury (NIH/NCATS)
[E]
<sury.vepa@nih.gov>;
Portilla, Lili (NIH/NCATS)
[E]

<portilll@ mail.nih.gov>
Subject: Re: Interview
request/chlorcyclizine
pricing: BuzzFeed News

Sorry Claire, meant to
copy Lili

Sent from my iPhone

On Oct 24, 2016, at

8:50 PM, Rohrbaugh,

Mark (NIH/OD) [E]
<RohrBauM@OD.NIH.GOV>

wrote:

Sent from
my iPhone

Begin
forwarded
message:

From:

"Fine,

Amanda

(NIH/OD)

[E]"
<amanda.fine@nih.gov>
Date:

October

To:
"Rohrbaugh,
Mark
(NIH/OD)
[E] "
<RohrBauM@OD.NIH.GOV>
Ce:
"McBurney,
Margaret
(NIH/OD)
[E] "

<mmcbumey@od.nih.gov>,
"Hardesty,

Rebecca

(NIH/OD)

[C]"

<rebecca.hardes nih.gov>,
"Myles,

Renate

(NIH/OD)

[E]"
<mylesr@od.nih.gov>,

"W ojtowicz,

Emma

(NIH/OD)

[E]"
<emma.wojtowicz@nih. gov>
Subject:

RE:

Interview
request/chlorcyclizine
pricing:

BuzzFeed

News

Thanks
Mark!
Hope
you're
not
working
while

on
vacation.

Amanda

From:

Rohrbaugh,

Mark

(NIH/OD)

[E]

Sent:

Monday,

October

24,

2016

3:22

PM

To:

Fine,

Amanda

(NIH/OD)

[E]
<amanda.fine@nih.gov>
Cc:

McBurney,

Margaret

(NIH/OD)

[E]
<mmcburney@od.nih.gov>;
Hardesty,

Rebecca

(NIH/OD)

[C]
<rebecca.hardesty@nih.gov>;
Myles,

Renate

(NIH/OD)

[E]
<mylesr@od.nih.gov>;
Wojtowicz,

Emma

(NIH/OD)

[E]
<emma.wojtowicz@nih.gov>
Subject:

Re:

Interview
request/chlorcyclizine
pricing:

BuzzFeed

News

I
am
available.

Looks
ok
to
me.

Not
sure
why
the
email
thread
was
released
under
FOIA.

There
is
more
one
could
say
but
this
is

the
basic

message.

Sent

from

my

iPhone

On

Oct

24,

2016,

at

8:10

PM,

Fine,

Amanda

(NIH/OD)

[E]

<amanda.fine@nih.gov>

wrote:
Greetings-
I'm
including
all
three
of
you
per
Mark’s
out
of
office
and
given
that
the
reporter's
deadline
is
October
28.
NIDDK
received
the

below

inquiry
from

Dan
Vergano
at
Buzzfeed
regarding
Knowledge
Ecology
International’s
(KEI)
questions
about
the

drug
chlorcyclizine
which
had/has
a

small
trial

at

the

CC:
Attached
is

a

back

and

forth
with
NIDDK/NCATS
that

KEI

got
through
FOIA.
Dan’s
questions
are
below

advance
for

your
input
and
guidance,
Amanda

Amanda
Fine
Deputy,
News
Media
Branch
National
Institutes
of
Health
Tel:

301-

49 6-
7246
Email:

amanda fine@nih.gov
Web:

http://www nih.gov

NIH

Turning
Discovery
Into
Health

From:

Payne,

January
(NIH/NIDDK)

[E]

Sent:

Monday,
October

24,

2016

2:54

PM

To:
OCPLPressTeam
<OCPLPressTeam@od.nih.gov>;
ODOCPL
Interviews
(NIH/OD

OCPL

)
<ODOCPLInterviews@mail.nih.gov>
Cc:

NIDDK
NIDDKMEDIA
(NIH/NIDDK)

<niddkmedia@niddk.nih.gov>

Subject:

Interview
request/chlorcyclizine
pricing:

BuzzFeed

News

Hello,
NIDDK
received
an
interview
request
from

a
Buzzfeed
reporter
asking
about
NIH
involvement
in
licensing
and

drug
pricing
for
chlorcyclizine.
Chuck
Niebylski,
director
of
NIDDK’s
Technology
Advancement
Office,
asked
that

|

refer

this
request
to

NIH

OD

as

it
involves
NIH’s
policy

on

drug
pricing.

Below

is

the
complete

email
exchange
I’ve

had

with

the
reporter,
Dan
Vergano,
and
attached

an
email

chain
between
NIH
employees
that

the
reporter
received
via

a

public
interest
group
called
Knowledge
Ecology
International,
which
obtained
the

records

via

a

FOIA
request.
(Please
note,

for
background:
KEI

also

published

able

to
respond
to

this
request?

Thank
you,
January

Communications
and

Public
Liaison
National
Institute

of
Diabetes
and
Digestive
and

Kidney
Diseases
NATIONAL
INSTITUTES
OF
HEALTH
Direct

301-

435-

8115

Cell
(b) (6)

Office
301-
496-
3583

www.niddk.nih.gov
NIH...Turning

Discovery
Into

Health®

[-2]

Celebration
of

Science

at

Z |

H:

Watch
how
medical
research
saves
lives

and
improves
health

From:

Dan
Vergano
[mailto:dan.vergano@buzzfeed.com]
Sent:
Monday,
October

24,

2016

12:29

PM

To:

Payne,
January
(NIH/NIDDK)
[E]
<january.payne@nih.gov>
Subject:

Re:
BuzzFeed
News:

press
contact

/

licensing

January,

Thanks
for
getting
back

to

me

deadline
10/28/16
M
DT

is

FinteclslelsTsserctstsentste. fellas! 2

responses
to
smarter
questions
on

all

this

that

your
folks
might
have.

Any
help
appreciated,

Dan
Vergano
BuzzFeed

Science
Reporter
(DC)

BuzzFeed

1630
Connecticut
Ave.

7th

Floor,
Washington
DC

20009

link:
https://s3.amazonaws.com/public-
inspection.federalregister.gov/2015-
06974.pdf

Dan
Vergano
|
Science
Reporter
(DC)

|

202

629
4563

BuzzFeed

1630
Connecticut
Ave.

7th

Floor,
Washington
DC

20009

(NIH/NIDDK)

[E]
<january.payne@nih.gov>
wrote:

Dear
Dan,

Thanks

for

your
message.
Can

you

please
provide
more
information

can
look
into
your
request?

you
please
briefly
describe
the
issue
that

has
been
raised?
Also,
what

is

the

of

the
public
interest
group?

e

What

is

your
hard
deadline?

e

Can

you
please
provide

a

few
examples
of
questions
you'd

like

to

ask?

Best,
January

W.

Payne
Office

of
Communications
and

Public
Liaison
National
Institute

of

Diabetes
and
Digestive
and

Kidney
Diseases
NATIONAL
INSTITUTES
OF
HEALTH

www.niddk.nih.gov

NIH...Turning
Discovery
Into

Health®

Celebration
of

Science

at

NIH:
Watch
how
medical
research
saves

lives

and
improves
health

From:

Dan

Vergano
[mailto:dan.vergano@buzzfeed.com]
Sent:
Monday,
October

24,

2016

11:25

AM

To:

NIDDK
NIDDKMEDIA
(NIH/NIDDK)
<niddkmedia@niddk.nih.gov>
Subject:
Fwd:
BuzzFeed
News:

press
contact

/

licensing

Krysten's

email
responder
suggested
I

send

this

note

to

this
contact.

Ms.

2

B
©
5
=!
io)
s
9

BuzzFeed

1630
Connecticut

Ave.

7th

Floor,
Washington
DC

20009

JANUARY Senders
PAYNE Card

@ National
Institutes of
Health

National Institutes of
Health | 9000 Rockville
Pike, Bethesda, MD
20892, USA | Official
website of the National
Institutes of Health (NIH).
NIH is one of the world's
foremost medical
research centers. An
agency of...

[] January Payne
on LinkedIn

1H | 663K
followers |
a 6K tweets - 5

hours ago

There's still time to
submit your

@NIH_ LRP
application! Get
started on yours
today. Deadline is
Nov.15

bit.ly/2e7QDzt
“studentdebt

Search for

January Payne
on le

Jan

<Reasonable

Pricing
Virotas
NIA
.pdf>
<image001.jpg>
<image001.jpg>
<image001.jpg>
<image001.jpg>

[-2]

[2